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U.S. Department of Health and Human Services

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Enforcement Report for May 6, 2009

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

 

May 6, 2009
09-18

 

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

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PRODUCT 
Russell Hobbs Mona Cordless Jug Kettle: a cordless electric kettle about 10” high, silver brushed matte finish stainless steel body with a black handle and base, with “Russell Hobbs” imprinted on the lower side of the kettle, 1 liter/32 fl. oz. capacity. Model RHMK 3022, Recall # F-200-9
CODE
All units
RECALLING FIRM/MANUFACTURER
Recalling Firm: Salton, Inc., Miramar, FL, by e-mail, letter and telephone beginning on February 13, 2009.
Manufacturer: Chiaphua Industries Limited, Hong Kong SAR. Firm initiated recall is ongoing.
REASON
This product was previously recalled in 2005 (FDA Recall # F-292-5).  This classification was based on high levels of leachable lead found in the kettle due to the use of lead solder in the product’s manufacturing.
VOLUME OF PRODUCT IN COMMERCE
2,500 units
DISTRIBUTION
KS
___________________________________
PRODUCT 
a) Mixed Apples and Dip, Red & Green Apples & Dip, net wt. 6.5 oz.; UPC 3597118009. Recall # F-201-9;

b) Apples Medley, net wt. 12 oz.; UPC 3597138860. Recall # F-202-9;

c)  Apple & Caramel Tray, net wt. 24 oz.; UPC 3597119304. Recall # F-203-9;

d) SM. Fruit Tray, net wt. 36 oz.; UPC 3597124646. Recall # F-204-9;

e) Apple Grape Tray with Caramel, net wt. 48 oz.; UPC 3597119300. Recall # F-205-9
CODE
All lots with sell by dates of 1/12/09 through 1/20/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pearson Foods Corp., Grand Rapids, MI, by telephone on January 12, 2009.
Manufacturer: Sunset Orchard, Richland Center, WI. Firm initiated recall is complete.
REASON
The sliced apples were recalled by the supplier because of potential contamination with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
470 cases
DISTRIBUTION
IL, IN, MI, OH
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PRODUCT 
a) Peanut Butter Cookie Dough under the Blue Ribbon Ultimate Gourmet brand name in 3 lb. tubs (Item #4104; UPC #73367 00043) and 3 lb. boxes (Item #5104; UPC #73367 00034 and
b) Peanut Butter Cookie Dough under the Little Lambs Gourmet brand name in 3 lb. boxes (Item #5104 B, 48 - 1oz. portions [pre-portioned]; UPC #73367 00034). Recall # F-208-9
CODE
a) All products shipped from 01/01/2007 to 01/20/09;
b) All products shipped from 09/17/08 to 01/20/09
RECALLING FIRM/MANUFACTURER
Blue Ribbon Products Inc., Forney, TX, by letter starting January 22, 2009 and press release on February 3, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanut products recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
150,865 units
DISTRIBUTION
TX, IN, AR, LA, OK, IL, TN, FL, MS, WA, GA, CA, AL, CO, MO, and NM
___________________________________
PRODUCT 
Belfonte Gal. Square Home Run Sundae ice cream, UPC 83057-01023-9. Recall # F-209-9 
CODE
Date codes 04/08/2009 and 05/29/2009
RECALLING FIRM/MANUFACTURER
Belfonte Ice Cream & Dairy Foods Co, Kansas City, MO, by fax and telephone on February 5, 2009 and press release on February 6, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanut product recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
4856 units
DISTRIBUTION
OK, KS, MO

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II

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PRODUCT 
a) Hunn's Private Stock Kosher Dill Spears, deli style, Must Keep Refrigerated, 32 fl oz. (2 PT.) 946 ML, UPC 0 78872 83250, packed in glass jars. Recall # F-206-9;

b) Goldin Chicago Style Spears, 3.5 Gal (13.25 L), and 5 Gal (18.95 L), Keep Refrigerated. UPC for 3.5 Gal is 0-78872-80635-8 and product is packed in plastic jars. UPC for 5 Gal. is 0-78872-80605-1 and product is packed in 5 gallon white buckets. Recall # F-207-9
CODE
Product shipped prior to March 20, 2009.
RECALLING FIRM/MANUFACTURER
First Place Foods, LLC, Garland, TX, by letter beginning March 20, 2009. Firm initiated recall is ongoing.
REASON
Ready to eat products contain undeclared color, FD&C Yellow #5.
VOLUME OF PRODUCT IN COMMERCE
3,509 units
DISTRIBUTION
TX, OK

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

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PRODUCT 
a) Ther-Rx Gynazole-1 (butoconazole nitrate) Vaginal Cream, 2%, NDC 64011-001-08, 5.8 gm, prefilled disposable applicator, Rx. Recall # D-238-2009;

b) Ther-Rx Clindesse (clindamycin phosphate) Vaginal Cream, 2%, 5.8 gm prefilled applicator, NDC 64011-124-08, Rx, Recall # D-239-2009;

c) Ther-Rx microK Extencaps (potassium chloride) 8mEq, packaged in 100-ct. bottles (NDC 64011-010-04), 100-ct. unit dose cartons (NDC 64011-010-11), and 500-ct. bottles (NDC 64011-010-08). Rx. Recall # D-240-2009;

d) Ther-Rx microK Extencaps (potassium chloride) 10mEq, packaged in 100-ct. bottles (NDC 64011-009-04), 100-ct. unit dose cartons (NDC 64011-009-11), and 500-ct. bottles (NDC 64011-009-08). Rx. Recall # D-241-2009
CODE
a) Lots 71691, 71692, 72162, 73822, 75838, 75839, 75840, 81067, 81068, 81069, 81070, 82030, 83183, 83184, 94684 and 99735 for domestic sales; Lots 83176, 83177, 85476, 85477, 85478, 85479, 85480, 85481, 85484, 85485, 85486, G6C960, G65960, G66961, G66962, G67960, G67961, G67962, G7A960, G7B960, G7B961, G7B962, G74960, G75961, G75962, G77960, G78962, G78963, G81960, G82960, G82961, G83960, G83961, G83962, G85960, G85961, G85962, G85963, G88960, G88961, G88962, G6B920, G61920, G62921, G63920, G63921, G63922, G65920, G65921, G65922, G65923, G65924, G67920, 80462, 75458, 77904, 72200, 76460, 77824, 81106 and 87420 for international sales; with exp. dates between 3/2009-10/2011;

b) Lots 79475, 81099, 81100, 81101, 81105, 83178, 83179, 90008, 91550, 93563, 94654, 96449 and 99727 with exp. dates between 2/2009-9/2010;

c) 100-ct. bottles - Lots 73739, 73740, 76448, 76530, 76531, 86343, 91228 and 91699 with Exp. dates between 5/2009-4/2011; Unit dose packaging - Lots 77179 and 84032 with Exp. dates between 12/2009-2/2010; 500-ct. bottles - Lots 63739, 73741, 76452, 80917, 82766 and 91519 with Exp. dates between 5/2009-8/2011;

d) 100 ct. bottles - Lots 71601, 72249, 80916, 84029 and 94671 with Exp. dates between 2/2009-11/2011; Unit dose carton - Lot 75798, Exp. date 5/2009; 500-ct. bottles - Lots 73802, 81084 and 94672 with Exp. dates between 5/2010-9/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ther-Rx Corp., Bridgeton, MO, by press release and letter on January 28, 2009 an additional press release and letter dated February 3, 2009.
Manufacturer: KV Pharmaceutical Co Westport, Saint Louis, MO. Firm initiated recall is ongoing.
REASON
The products were not manufactured in conformance with GMP's
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide and countries of Indonesia, Singapore, Switzerland, Hungary, Canada, Brazil, Australia
__________________________________
PRODUCT 
1) Dextroamphetamine Sulfate Tablets, USP, 5 mg, CII, packaged in 100 count bottles, Rx Only, NDC 58177-311-04, Recall #  D-257-2009;

2) Dextroamphetamine Sulfate Tablets, USP, CII, 10 mg., packaged in 100 count bottles, Rx Only, NDC 58177-312-04, Recall # D-258-2009;

3) Hydromorphone Hydrochloride Tablets, USP, CII, 2 mg, packaged in 100 count bottles (NDC 58177-620-04) and 100 count blister cartons (NDC 58177-620-11), Rx Only, Recall # D-259-2009;

4) Hydromorphone Hydrochloride Tablets, USP, 4 mg, CII, packaged in 100 count bottles (NDC 58177-621-04), and in 100 count unit dose blister cartons (NDC 58177-621-11), Rx Only, Recall # D-260-2009;

5) Hydromorphone Hydrochloride Tablets, USP, 8 mg, CII packaged in 100 count bottles, NDC 58177-449-04, Rx Only, Recall # D-261-2009;

6) Isosorbide Mononitrate Extended-Release Tablets, 30 mg, packaged in 100 count bottles, (NDC 58177-222-04), 500 count bottles (NDC 58177-222-08), and 100 count cartons unit-dose blisters (NDC 58177-222-11), Rx Only, Recall # D-262-2009;

7) Isosorbide Mononitrate Extended-Release Tablets, 60 mg, packaged in 100 count bottles (NDC 58177-238-04), 500 count bottles (NDC 58177-238-08), and 100 count cartons unit-dose blisters (NDC 58177-238-11), Rx Only, Recall # D-263-2009;

8) Isosorbide Mononitrate Extended-Release Tablets, 120 mg, packaged in 100 count bottles, NDC 58177-201-04, Rx Only, Recall # D-264-2009;

9) Metoprolol Succinate Extended-release Tablets, USP, 25 mg, packaged in 100 count bottles (NDC 58177-293-04), 1,000 count bottles (NDC 58177-293-09), and 100 count unit-dose cartons. (NDC 58177-293-11), Rx Only, Recall # D-265-2009;

10) Metoprolol Succinate Extended-release Tablets, USP, 50 mg, packaged in 100 count bottles (NDC 58177-369-04), 1,000 count bottles (NDC 58177-369-09), and 100 count unit-dose cartons (NDC 58177-369-11), Rx Only, Recall # D-266-2009;

11) Metoprolol Succinate Extended-release Tablets, USP, 100 mg, packaged in 100 count bottles (NDC 58177-368-04), 1,000 count bottles (NDC 58177-368-09), and 100 count unit-dose cartons (NDC 58177-368-11), Rx Only, Recall # D-267-2009;

12) Metoprolol Succinate Extended-release Tablets, USP, 200 mg, packaged in 100 count bottles (NDC 58177-358-04) and 1,000 count bottles (NDC 58177-358-09), Rx Only, Recall # D-268-2009;

13) Morphine Sulfate Extended-release Tablets, 15 mg, CII packaged in 100 count bottles, Rx Only, NDC 58177-310-04, Recall # D-269-2009;

14) Morphine Sulfate Extended-Release Tablets, 30 mg, CII packaged in 100 count bottles (NDC 58177-320-04), Rx Only, Recall # D-270-2009;

15) Morphine Sulfate Extended-Release Tablets, 60 mg, CII packaged in 100 count bottles (NDC 58177-330-04), Rx Only, Recall # D-271-2009;

16) Morphine Sulfate Extended-Release Tablets, 100 mg, CII, packaged in 100 count bottles, Rx Only, NDC 58177-340-04, Recall # D-272-2009;

17) Morphine Sulfate Extended-Release Tablets, 200 mg, CII packaged in 100 count bottles, Rx Only, NDC 58177-380-04, Recall # D-273-2009;

18) Morphine Sulfate Immediate-Release Oral Tablets, 15 mg, CII, packaged in 100 count bottles, Rx Only, NDC 58177-313-04, Recall # D-274-2009;

19) Morphine Sulfate Immediate-Release Oral Tablets 30 mg, CII, packaged in 100 count bottles, Rx Only, NDC 58177-314-04, Recall # D-275-2009;

20) Propafenone HCl Tablets 150 mg, packaged in 100 count bottles (NDC 58177-331-04) and 100 count unit dose cartons (NDC 58177-331-11), Rx Only, Recall # D-276-2009;

21) Propafenone HCl Tablets 225 mg, packaged in 100-count bottles, RX, NDC 58177-332-04, Recall # D-277-2009;

22) Propafenone HCl Tablets 300 mg, packaged in 100 count bottles, Rx Only, NDC 58177-333-04, Recall # D-278-2009;

23) Benazepril Hydrochloride Cl Tablets 5 mg, packaged in 100 count bottles, RX, NDC 58177-341-04, Recall # D-279-2009;

24) Benazepril Hydrochloride Tablets 10 mg, packaged in 100-count bottles. (NDC 58177-342-04) and 500-count bottles (NDC 58177-342-08), RX, Recall # D-280-2009; 

25) Benazepril Hydrochloride Tablets 20 mg, packaged in 100-count bottles (NDC 58177-343-04) and 500-count bottles (NDC 58177-343-08), RX, Recall # D-281-2009; 

26) Benazepril HCl Tablets 40 mg, packaged in 100-count bottles (NDC 58177-344-04) and 500-count bottles (NDC 58177-344-08, RX, Recall # D-282-2009;

27) Benzonatate Capsules 100 mg, packaged in 100-count bottles (NDC 58177-091-04), 100-count unit dose cartons (NDC 58177-091-11), and 500-count bottles (NDC 58177-091-08), RX, Recall # D-283-2009;

28) Benzonatate Capsules 200 mg, packaged in 100-count bottles, RX, NDC 58177-092-04. Recall # D-284-2009;

29) Bromfenex, Brompheniramine Maleate/Pseudoephedrine HCl, Extended-Release Capsules, 12 mg/120 mg, packaged in 100-count bottles, NDC 58177-019-04, RX. Recall # D-285-2009;

30) Bromfenex PD, Brompheniramine Maleate/Pseudoephedrine HCl, Extended-Release Capsules, 6 mg/60 mg, packaged in 100-count bottles, RX, NDC 58177-020-04, Recall # D-286-2009;

31) Buspirone HCl Tablets, USP, 5 mg, packaged in 100 count bottles (NDC 58177-264-04) and 500-count bottles (NDC 58177-264-08), RX, Recall # D-287-2009;

32) Buspirone HCl Tablets, USP, 10 mg, packaged in 100 count bottles (NDC 58177-265-04) and 500 count bottles (NDC 58177-265-08), RX, Recall # D-288-2009;

33) Buspirone HCl Tablets, USP, 15 mg, packaged in 100 count bottles (NDC 58177-309-04) and 500 count. bottles (NDC 58177-309-08), RX, Recall # D-289-2009;

34) Codeine Phosphate and Guaifenesin Tablets, CIII, 10 mg/300 mg, packaged in 100 count bottles, RX, NDC 58177-223-04, Recall # D-290-2009;

35) Diltiazem HCl Extended-release Capsules (Once-a-Day Dosage) 120 mg, packaged in 30 count bottles (NDC 58177-061-19) and 90 count bottles (NDC 58177-061-26), RX, Recall # D-291-2009;

36) Diltiazem HCl Extended-Release Capsules (Once-a-Day Dosage) 180 mg, packaged in 30 count bottles (NDC 58177-062-19), 90 count bottles (NDC 58177-062-26), and 100 count unit dose cartons (NDC 58177-062-11, RX, Recall # D-292-2009;

37) Diltiazem HCl Extended-release Capsules 240 mg, packaged in 30 count bottles (NDC 58177-063-19), 90 count bottles (NDC 58177-063-26), and 100 count unit dose cartons (NDC 58177-063-11), RX, (NDC 58177-063-09, 1,000-count. bottles, not affected by recall), Recall # D-293-2009; 

38) Diltiazem HCl Extended-release Capsules (Once-a-Day Dosage) 300 mg, packaged in 30 count bottles (NDC 58177-064-19) and 90-count bottles (NDC 58177-064-26), RX, Recall # D-294-2009;

39) Diltiazem HCl Extended-release Capsules (Once-a-Day Dosage) 360 mg, packaged in 30 count bottles (NDC 58177-065-19), 90 count bottles (NDC 58177-065-26), and 100 count unit dose cartons (58177-065-11), RX, (NDC 58177-065-09, 1,000-count bottles not affected by recall), Recall # D-295-2009; 

40) Diltiazem HCl Extended-release Capsules (Once-a-Day Dosage) 420 mg, packaged in 30 count bottles (NDC 58177-066-19), 90 count bottles (NDC 58177-066-26), RX. (NDC 58177-066-09, 1,000-count bottles not affected by recall), Recall # D-296-2009; 

41) Disopyramide Phosphate Extended-release Capsules, USP, 150 mg, packaged in 100 count bottles, RX, NDC 58177-002-04, Recall # D-297-2009;

42) Doxazosin Mesylate Tablets, 1 mg, packaged in 100 count bottles (NDC 58177-266-04) and 500 count bottles (NDC 58177-266-08), RX, Recall # D-298-2009;

43) Doxazosin Mesylate Tablets 2 mg, packaged in 100 count bottles (NDC 58177-267-04) and 500 count bottles (NDC 58177- 267-08), RX, Recall # D-299-2009;

44) Doxazosin Mesylate Tablets 4 mg, packaged in 100 count bottles (NDC 58177-268-04) and 500 count bottles (NDC 58177-268-08), RX, Recall # D-300-2009;

45) Doxazosin Mesylate Tablets 8 mg, packaged in 100 count bottles (NDC 58177-269-04) and 500 count bottles (NDC 58177-269-08), RX, Recall # D-301-2009;

46) EtheDent Chewable Tablets 0.25 mg F, (From 0.55 mg sodium fluoride), Sodium Fluoride Chewable Tablets, Vanilla Flavored, packaged in 120 count bottles, RX, NDC 58177-432-40, Recall # D-302-2009;

47) EtheDent Chewable Tablets, 0.5 mg F, (From 1.1 mg sodium fluoride) Sodium Fluoride Chewable Tablets, Grape Flavored, packaged in 120 count bottles (NDC 58177-433-40) and 1,000 count bottles (NDC 58177-433-09), RX, Recall # D-303-2009;

48) EtheDent Chewable Tablets, 1 mg, F (From 2.2 mg. sodium fluoride), Sodium Fluoride Chewable Tablets, Cherry Flavored, packaged in 120 count bottles (NDC 58177-434-40) and 1,000 count bottles, (NDC 58177-434-09), RX, Recall # D-304-2009;

49) EthexDerm BPW-5, Benzoyl Peroxide Topical Wash 5%, packaged in 8 oz. tubes, RX, NDC 58177-928-65, Recall # D-305-2009;

50) EthexDerm BPW-10, Benzoyl Peroxide Topical Wash 10%, packaged in 8 oz tubes, RX, NDC 58177-929-65, Recall # D-306-2009;

51) ETHEZYME 650 Papain-Urea Debriding Ointment, each gram contains Papain, USP (6.5 x 10 5 USP units of activity) and 100 mg Urea, USP, packaged in 1 oz tubes, RX, NDC 58177-868-02, Recall # D-307-2009;

52) ETHEZYME 830 Papain-Urea Debriding Ointment, each gram contains Papain, USP (8.3 x 10 5 USP units of activity) and 100 mg Urea, USP, packaged in 1 oz (30 gm) tubes, RX, NDC 58177-816-02, Recall # D-308-2009;

53) Ethezyme Papain-Urea Debriding Ointment, each gram contains Papain (1.1 x 10 6 USP units of activity) and 100 mg Urea, packaged in 1 oz tubes, RX, NDC 58177-804-02, Recall # D-309-2009; 

54) ETH-Oxydose (oxycodone hydrochloride) Oral Concentrate Solution, CII, 20 mg/1 mL, packaged in 1 fl oz bottles (NDC 58177-914-01), and 30/1 mL InveAmp ampoules (NDC 58177-914-56), RX, Recall # D-310-2009;

55) Guaifenex DM, Guaifenesin/Dextromethorphan HBr Extended-Release Tablets, 600 mg/30 mg, packaged in 100 count bottles, RX, NDC 58177-213-04, D-311-2009;

56) Guaifenex GP, Guaifenesin/Pseudoephedrine HCl Extended-release Tablets, 1200 mg/120 mg, packaged in 100 count bottles, RX, NDC 58177-373-04, Recall # D-312-2009;

57) Guaifenex PSE 60 Guaifenesin/Pseudoephedrine HCl Extended-Release Tablets, 600 mg/60 mg, packaged in 100 count bottles, RX, NDC 58177-214-04, Recall # D-313-2009;

58) Guaifenex PSE 120, Guaifenesin/Pseudoephedrine HCl Extended-Release Tablets, 600 mg/120 mg, packaged in 100 count bottles, RX, NDC 58177-208-04, Recall # D-314-2009;

59) Guaifenex PSE 80, Guaifenesin/Pseudoephedrine HCl Extended-Release Tablets, 800 mg/80 mg, packaged in 100 count bottles, RX, NDC 58177-413-04, Recall # D-315-2009;

60) Guaifenex PSE 85, Guaifenesin/Pseudoephedrine HCl Extended-Release Tablets, 795 mg/85 mg, packaged in 100 count bottles, RX, NDC 58177-478-04, Recall # D-316-2009;

61) Hista-Vent DA Extended-Release Tablets, Chlorpheniramine Maleate/Phenylephrine Hydrochloride/Methscopolamine Nitrate, 8 mg/20 mg/2.5 mg, packaged in 100 count bottles, RX, NDC 58177-227-04, Recall # D-317-2009;

62) Hista-Vent PSE Tablets, Pseudoephedrine HCl, Chlorpheniramine Maleate/Methscopolamine Nitrate, 120 mg/8 mg/2.5 mg, packaged in 100 count bottles, RX, NDC 58177-426-04, Recall # D-318-2009;

63) Histinex HC Syrup, CIII, containing in each 5 mL: 2.5 mg Hydrocodone bitartrate, 5.0 mg Phenylephrine hydrochloride, and 2.0 mg Chlorpheniramine maleate, packaged in 16 fl oz bottles (NDC 58177-877-07) and 32 fl oz bottles (NDC 58177-877-12), RX, Recall # D-319-2009;

64) Histinex PV Liquid, containing in each 5 mL: 2.5 mg Hydrocodone Bitartrate, 30 mg Pseudoephedrine Hydrochloride, and 2.0 mg Chlorpheniramine Maleate, packaged in 16 fl oz bottles, RX, NDC 58177-883-07, Recall # D-320-2009;

65) Hydrocodone Bitartrate & Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, packaged in 16 fl oz bottles, RX, NDC 58177-909-07, Recall # D-321-2009;

66) Hydrocodone Bitartrate/Guaifenesin Liquid, CIII, containing in each 5 mL: 5 mg Hydrocodone Bitartrate and 100 mg Guaifenesin, packaged in 16 fl oz bottles, RX, NDC 58177-881-07, Recall # D-322-2009;

67) Hydrocortisone and Iodoquinol Cream 1%, packaged in 1 oz tubes, RX, NDC 58177-803-02, Recall # D-323-2009;

68) Hydroquinone 4% Cream Skin Bleaching Cream, packaged in 1 oz tubes, RX, NDC 58177-801-02, Recall # D-324-2009;

69) Hydroquinone 4% Cream with Sunscreens Skin Bleaching Cream, packaged in 1 oz tubes, RX, NDC 58177-802-02, Recall # D-325-2009;

70) Hydro-Tussin CBX Syrup, containing 2 mg/5 mL Carbinoxamine Maleate and 25 mg/5 mL Pseudoephedrine Hydrochloride, packaged in 16 fl oz, NDC 58177-924-07,
Recall # D-326-2009;

71) Hydro-Tussin DHC Syrup, CIII, containing 7.5 mg/5 mL Dihydrocodeine Bitartrate, 2 mg/5 mL Chlorpheniramine Maleate, and 15 mg/5 mL Pseudoephedrine Hydrochloride, packaged in 16 fl oz bottles, RX, NDC 58177-926-07, Recall # D-327-2009;

72) Hydro-Tussin DM Liquid, containing 200 mg/5 mL Guaifenesin, and 20 mg/5 mL Dextromethorphan hydrobromide, packaged in 16 fl oz bottles, RX, NDC 58177-906-07,:
Recall # D-328-2009;

73) Hydro-Tussin EXP Syrup, CIII, containing 7.5 mg/5 mL Dihydrocodeine bitartrate, 15 mg/5 mL Pseudoephedrine Hydrochloride, and 100 mg/5 mL Guaifenesin, packaged in 16 fl oz bottles, RX, NDC 58177-927-07, Recall # D-329-2009;

74) Hydro-Tussin HC Syrup, CIII, containing 3 mg/5 mL Hydrocodone bitartrate, 2 mg/5 mL Chlorpheniramine maleate, and 15 mg/5 mL Pseudoephedrine hydrochloride, packaged in 16 fl oz bottles, RX, NDC 58177-915-07, Recall # D-330-2009;

75) Hydro-Tussin HD Syrup, CIII, containing 100 mg/5 mL Guaifenesin, 30 mg/5 mL Pseudoephedrine hydrochloride and 2.5 mg/5 mL Hydrocodone bitartrate, packaged in 16 fl oz bottles, RX, NDC 58177-890-07, Recall # D-331-2009;

76) Hydro-Tussin XP Syrup, CIII, containing 3 mg/5 mL Hydrocodone bitartrate, 15 mg/5 mL Pseudoephedrine hydrochloride, and 100 mg/5 mL Guaifenesin, packaged in 16 fl oz bottles, RX, NDC 58177-916-07, Recall # D-332-2009;

77) Hyoscyamine Orally Disintegrating Tablets 0.125 mg, packaged in 100 count bottles, RX, NDC 58177-423-04, Recall # D-333-2009;

78) Hyoscyamine Sublingual Tablets, USP 0.125 mg, packaged in 100 count bottles, RX, NDC 58177-255-04, Recall # D-334-2009; 

79) Hyoscyamine Sulfate Extended-Release Capsules 0.375 mg, packaged in 100 count bottles, Rx, NDC 58177-017-04, Recall # D-335-2009;

80) Hyoscyamine Sulfate Extended-Release Tablets 0.375 mg, packaged in 100 count bottles, Rx, NDC 58177-237-04, Recall # D-336-2009;

81) Hyoscyamine Sulfate Oral Tablets 0.125 mg, packaged in 100 count bottles, Rx, NDC 58177-274-04, Recall # D-337-2009;

82) Potassium Chloride Extended-Release Tablets, USP, 1500 mg (20 mEq), packaged in 100 count bottles (NDC 58177-202-04), 500 tablet bottles (NDC 58177-202-08), and 1000 tablet bottles (NDC 58177-202-09), Rx only, Recall # D-338-2009;

83) Meperidine HCl and Promethazine HCl Capsules, 50 mg /25 mg, 100 count bottles, NDC 58177-027-04, Recall # D-339-2009;

84) Morphine Sulfate Concentrated Oral Solution 20 mg/1 mL, packaged in 1/2 fl oz (15 mL) bottles (NDC 58177-886-57); packaged in 1 fl oz (30 mL) bottles (NDC 58177-886-01); packaged in 4 fl oz (120 mL) bottles (NDC 58177-886-03); and packaged in 8 fl oz (240 mL) bottles (NDC 58177-886-05), Recall # D-340-2009;

85) Morphine Sulfate InveAmp immediate-release CONCENTRATED oral solution 5 mg/0.25 mL, NDC 58177-888-80, packaged as follows: Unit dose package of 30 InveAmp" ampoules (each ampoule contains 0.25 mL), Recall # D-341-2009;

86) Morphine Sulfate InveAmp 20 mg/1 mL immediate-release CONCENTRATED oral solution, NDC 58177-888-56, packaged as follows: Unit dose package of 30 InveAmp" ampoules (each ampoule contains 1 mL), Recall # D-342-2009;

87) NitroQuick (nitroglycerin) Sublingual Tablets, USP 0.3 mg, NDC 58177-323-04, packaged in 100 tablet bottles, Rx only, Recall # D-343-2009;

88) NitroQuick (nitroglycerin) Sublingual Tablets 0.4 mg, packaged in convenience box containing 4 - 25 tablet bottles (NDC 58177-324-18) and 100 tablet bottles (NDC 58177-324-04), Rx Only, Recall # D-344-2009;

89) NitroQuick (nitroglycerin) Sublingual Tablets 0.6 mg, NDC 58177-325-04, packaged in 100 tablet bottles, Rx Only, Recall # D-345-2009;

90) Nystatin Topical Powder, USP, (100,000 USP units per gram) 15 grams per bottle, NDC 58177-839-45, Rx Only, Recall # D-346-2009;

91) Nystatin Topical Powder, USP (100,000 UPS units per gram) 30 grams per bottle, NDC 58177-839-46, Rx Only, Recall # D-347-2009;

92) Nystatin Topical Powder, USP (100,000 USP units per gram) 60 grams per bottle, NDC 58177-839-61, Rx Only, Recall # D-348-2009;

93) Ondansetron Orally Disintegrating Tablets, 4 mg, NDC 58177-363-22, packaged in 3 - 10 tablet blister pack boxes (30 tablets), Rx Only, Recall # D-349-2009;

94) Ondansetron Orally Disintegrating Tablets, 8 mg, packaged in a 10 tablet blister pack box (10 tablets) (NDC 58177-364-56) and packaged in 3 - 10 tablet blister pack boxes (30 tablet) (NDC 58177364-22), Rx Only, Recall # D-350-2009; 

95) Oxycodone Hydrochloride Immediate-Release Capsules, USP, 5 mg, CII, 100 count bottle (NDC 58177-041-04) and 10 - 10 Unit Dose packs per box (NDC 58177-041-11), Rx Only, Recall # D-351-2009;

96) Oxycodone Hydrochloride Tablets, USP, 5 mg, CII, packaged in 100 tablet bottles (NDC 58177-625-04) and 10 -10 tablet blister packs (NDC 58177-625-11), Rx Only, Recall # D-352-2009;

97) Oxycodone Hydrochloride Tablets, USP, 10 mg, CII, packaged in 100 count bottles, NDC 58177-461-04, Rx Only, Recall # D-353-2009;

98) Oxycodone Hydrochloride Tablets, USP, 15 mg, CII, packaged in 100 count bottles, NDC 58177-445-04, Rx Only, Recall # D-354-2009;

99) Oxycodone Hydrochloride Tablets, USP, 20 mg, CII, packaged in 100 count bottles, NDC 58177-462-04, Rx Only, Recall # D-355-2009;

100) Oxycodone Hydrochloride Tablets, USP, 30 mg, CII, packaged in 100 count bottles, NDC 58177-446-04, Rx Only, Recall # D-356-2009;

101) Pangestyme CN10 (pancrelipase, USP) delayed release capsules, packaged in 100 count bottles, NDC 58177-029-04, Rx Only, Recall # D-357-2009;

102) Pangestyme CN20 (pancrelipase, USP) delayed release capsules, packaged in 100 count bottles, NDC 58177-030-04, Rx Only, Recall # D-358-2009;

103) Pangestyme EC 100 (pancrelipase, USP) delayed release capsules, packaged in 100 count bottles, NDC 58177-031-04, Rx Only, Recall # D-359-2009;

104) Pangestyme EC 250 (pancrelipase, USP) delayed release capsules, packaged in 250 count bottles, NDC 58177-031-06, Rx Only, Recall # D-360-2009;

105) Pangestyme MT16 (pancrelipase, USP) delayed release capsules, packaged in 100 count bottles, NDC 58177-028-04, Rx Only, Recall # D-361-2009;

106) Pangestyme UL12 (pancrelipase, USP) delayed release capsules, packaged in 100 count bottles, NDC 58177-048-04, Rx Only, Recall # D-362-2009;

107) Pangestyme UL18 (pancrelipase, USP), packaged in 100 count bottles, NDC 58177-049-04, Rx Only, Recall # D-363-2009;

108) Pangestyme UL20 (pancrelipase, USP), packaged in 100 count bottles, NDC 58177-050-04, Rx Only, Recall # D-364-2009;

109) PhenaVent (Guaifenesin/Phenylephrine HCl), Extended-release Capsules, 400 mg/15 mg, packaged in 30 count bottles. NDC 58177-078-19, Rx Only, Recall # D-365-2009;

110) PhenaVent D (Guaifenesin/Phenylephrine Hydrochloride), Extended-release Tablets, 1200 mg/40 mg, packaged in 100 count bottles, NDC 58177-444-04, Rx Only, Recall # D-366-2009;

111) PhenaVent LA, phenylephrine extended-release/guaifenesin capsule, 30 mg/400 mg, packaged in 30 count bottles, NDC 58177-095-19, Rx Only, Recall # D-367-2009;

112) PhenaVent PED (Guaifenesin/Phenylephrine Hydrochloride), Extended-release Capsules, 200 mg/7.5 mg, packaged in 100 count bottles, NDC 58177-079-04, Rx Only, Recall #  D-368-2009;

113) Plaretase 8000 (pancrelipase USP), packaged in 100 tablet bottles (NDC 58177-416-04) and 500 tablet bottles (NDC 58177-416-08), Rx Only, Recall # D-369-2009;

114) Potassium Chloride Extended-Release Capsules, USP, 8 mEq (600 mg), packaged in 100 count bottles (NDC 58177-677-04) and 500 count bottles (NDC 58177-677-08), Rx Only, Recall # D-370-2009;

115) Potassium Chloride Extended-Release Capsules, USP, 10 mEq (750 mg), packaged in 100 count bottles (NDC 58177-001-04), 500 count bottles (NDC 58177-001-08) and 1000 count bottles (NDC 58177-001-09) and 10 - 10 count unit dose /blister packs - totaling 100 capsules (NDC 58177-001-11), Rx Only, Recall # D-371-2009;

116) Potassium Chloride Extended-Release Tablets, USP, 1500 mg (20 mEq), packaged in 10 - 10 count unit dose blister packs - totaling 100 tablet, NDC 58177-202-11, Rx Only, Recall # D-372-2009;

117) PrednisoLONE Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in 8 fl oz bottle, NDC 58177-932-05, Rx Only, Recall # D-373-2009;

118) PrednisoLONE Syrup, USP, 5 mg/5 mL, packaged in 120 mL bottles, NDC 58177-912-03, Rx Only, Recall # D-374-2009;

119) PrednisoLONE Syrup, USP, 15 mg/5 mL, packaged in 8 fl oz (240 mL) bottles (NDC 58177-910-05) and 16 fl oz (480 mL) bottles (NDC 58177-910-07), Rx Only, Recall # D-375-2009;

120) Pseudovent 400 (Pseudoephedrine HCl (extended-release)/Guaifenesin), Capsules, 120 mg/400 mg, packaged in 100 count bottles, NDC 58177-096-04, Rx Only, Recall D-376-2009;

121) Pseudovent (Guaifenesin/Pseudoephedrine HCl), Capsules, 250 mg/120 mg, packaged in 100 count bottles, NDC 58177-045-04, Rx Only, Recall # D-377-2009;

122) Pseudovent PED (Guaifenesin/Pseudoephedrine HCl), Capsules, 300 mg/60 mg, packaged in 100 count bottles, NDC 58177-046-04, Rx Only, Recall # D-378-2009;

123) Tri-Vent DM Syrup, Dextromethorphan HBr 15 mg, Pseudoephedrine Hydrochloride 40 mg, Guaifenesin 100 mg, packaged in 16 fl oz (480 mL) bottles, NDC 58177-925-07, Rx Only, Recall # D-379-2009;

124) Tri-Vent DPC Syrup, Dextromethorphan HBr 15 mg, Phenylephrine Hydrochloride 6 mg, Chlorpheniramine Maleate 2 mg, packaged in 16 fl oz (480 mL) bottles, NDC 58177-923-07, Rx Only, Recall # D-380-2009;

125) Tri-Vent HC Liquid, CIII, Hydrocodone Bitartrate 5 mg, Pseudoephedrine Hydrochloride 30 mg, Carbinoxamine Maleate 2 mg, packaged in 16 fl oz (473 mL) bottles, NDC 58177-920-07, Rx Only, Recall # D-381-2009;

126) Colgate Luride (Sodium Fluoride), 0.25 mg F, Lozi-Tabs, Vanilla Flavor, packaged in 120 count bottles, NDC 0126-0186-21, Rx Only, Recall # D-382-2009;

127) Colgate Luride (Sodium Fluoride), 0.5 mg F, Lozi-Tabs, Grape Flavor, packaged in 120 count bottles, NDC 0126-0014-21, Rx Only, Recall # D-383-2009;

128) Advanced NatalCare, Prenatal Vitamins, 90 tablet bottles, NDC 58177-350-26, Rx Only, Recall # D-384-2009;

129) Advanced-RF NatalCare, Prenatal Vitamins, 90 tablet bottles, NDC 58177-458-26, Rx Only, Recall # D-385-2009;

130) Anemagen Caplets, (contains Elemental Iron-as Sumalate/Succinic Acid/Vitamin C/Vitamin B12/Desiccated Stomach Substance), 90 count bottles, NDC 58177-672-26, Rx Only, Recall # D-386-2009;

131) nemagen Forte Caplets with Folic Acid, (contains Elemental Iron- as Sumalate/Ferrous Fumarate/Succinic Acid/Vitamin C/Folic Acid, USP/Vitamin B12), 90 caplet bottles, NDC 58177-671-26, Rx Only, Recall # D-387-2009;

132)  Cal-Nate, Prenatal Multivitamin/Multimineral with Dual Iron and Calcium Citrate, 90 tablet bottles NDC 581-935-26, Rx Only, Recall # D-388-2009;

133) CareNatal DHA Tablets, Prenatal Multivitamin/Multimineral Tablets and Omega-3 Fatty Acid, 30 tablets and 30 soft gelatin capsules, (packaged in a box with 5 unit dose blister cards of 6 tablets and 5 unit dose blister cards of 6 soft gelatin capsules), NDC 58177-618-66, Rx Only, Recall # D-389-2009;

134) ComBgen Tablets, Folic Acid 2.2 mg, Vitamin B6 25 mg, Vitamin B12 500 mcg, packaged in 100 count bottles, NDC 58177-440-04, Rx Only, Recall # D-390-2009;

135) CombiRx Tablets, packaged in 30 count bottles, NDC 58177-670-19, Rx Only,  Recall D-391-2009;

136) Conison Capsules, Hematinic Concentrate with Intrinsic Factor, packaged in 60 count bottles, NDC 58177-044-03, Rx Only, Recall # D-392-2009;

137) Fe-Tinic 150 Forte Capsules, packaged in 90 capsule bottles, NDC 58177-967-26, Rx Only, Recall # D-393-2009;

138) NataCaps, Prenatal Multivitamin/Mineral Capsules, packaged in 100 count bottles, NDC 58177-073-04, Rx Only, Recall # D-394-2009;

139) NatalCare Gloss Tabs, Prenatal Vitamins, packaged in 90 tablet bottles, NDC 58177-418-26, Rx Only, Recall # D-395-2009;

140) NatalCare PIC, Prenatal Multivitamin/Mineral Tablets with Polysaccharide-Iron Complex, packaged in 100 count bottles, NDC 58177-257-04, Rx Only, Recall # D-396-2009;  

141) NatalCare PIC Forte, Prenatal Multivitamin/Mineral Tablets with Polysaccharide-Iron Complex, packaged in 100 count bottles, NDC 58177-258-04, Rx Only, Recall # D-397-2009;

142) NatalCare Plus Tablets, Prenatal Multivitamin/Mineral Tablets, packaged in 100 count bottles, NDC 58177-225-04, Rx Only, Recall # D-398-2009;

143) NatalCare Rx, Prenatal Multivitamin/Mineral Tablets with Beta Carotene, packaged in 200 count bottles, NDC 58177-317-05, Rx Only, Recall # D-399-2009;

144) NatalCare Three, Prenatal Vitamins, packaged in 100 tablet bottles, NDC 58177-415-04, Rx Only, Recall # D-400-2009;

145) NataTab FA, Prenatal Vitamin and Mineral Tablets with Folic Acid, packaged in 100 count bottles, NDC 58177-329-04, Rx Only, Recall # D-401-2009;

146) NataTab Rx, Vitamins and Minerals with Folic Acid, packaged in 90 tablet bottles, NDC 58177-376-26, Rx Only, Recall # D-402-2009;

147) NutriNate Chewable, Chewable Prenatal Multivitamin Tablet with Iron, packaged in 90 tablet bottles, NDC 58177-351-26, Rx Only, Recall # D-403-2009;

148) Nutrispire, Vitamins and Minerals With Folic Acid, packaged in 90 tablet bottles, NDC 58177-463-26, Rx Only, Recall # D-404-2009;

149) Prenatal MR 90 Fe, Prenatal Multivitamin/Mineral Tablets with Micro-Release Iron, packaged in 100 count bottles, NDC 58177-212-04, Rx Only, Recall #  D-405-2009;

150) Prenatal MTR with Selenium, Prenatal Multivitamin/Mineral Tablets, packaged in 100 count bottles, NDC 58177-316-04, Rx Only, Recall # D-406-2009;

151) Prenatal Rx 1 (one tablet daily), Prenatal Multivitamin/Mineral Tablets, a) packaged in 100 count bottles (NDC 58177-216-04) and b) 10 x 10 unit dose blister packs (NDC 58177-216-11), Rx Only, Recall # D-407-2009;

152) Prenatal Z Advanced Formula, Prenatal Multivitamin/Mineral Tablets, packaged in 100 count bottles, NDC 58177-275-04, Rx Only, Recall # D-408-2009;

153) Ultra NatalCare, Prenatal Multivitamin/Multimineral Oral Tablets, packaged in 100 count bottles, NDC 58177-292-04, Rx Only, Recall # D-409-2009
CODE
1) Lots 77946, 81141, 81142, 97139, 98051, 98052 and 98053 with exp. dates ranging from 11/30/09-5/31/12;

2) Lots 73934, 75892, 77945, 81137, 86320, 90101, 98054, 98055 and 98056 with exp. dates ranging from 9/30/09-1/31/12;

3) Bottles - Lots 81934, 84107, 89870, 90217, 90218, 90219, 90220, 90221, 93462, 93463, 93464, 95327, 95328, 96348, 96349 and 99103 with exp. dates ranging from 4/30/09-9/30/10; Unit dose - Lots 81320, 81321, 81322, 81323, 88941, 89871, 90222, 90223, 93465, 93466, 96148, 96344 and 96345 with exp. dates ranging from 4/30/09-8/31/10;

4) Bottles - Lots 89867, 89868, 90224, 90225, 90226, 90227, 91671, 91672, 93467, 96152, 96153, 96351, 96352, 97151 and 97209 with exp. dates between 12/31/09-10/31/10; Unit dose - Lots 77845, 89866, 91673, 96151 and 99628 with exp. dates between 8/31/09-9/30/10;

5) Lots 76071, 81318, 81319, 89869, 90228 and 93468 with exp. dates ranging from 6/30/09-6/30/10;

6) 100-ct. bottles - Lots 63463, 63464, 63465, 63867, 63868, 66421, 66422, 66423, 66424, 68102, 69759, 71699, 72738, 74254, 74833, 75266, 75456, 75457, 75966, 76282, 76464, 79303, 81468, 82303, 82304, 83031, 83495, 83803, 84606, 84632, 87021, 87213, 87308, 87530, 87932, 89050, 89078, 90484, 90485, 90486, 90487, 90488, 90489, 90490, 91581, 91582, 91583, 92279, 92699, 92700, 92701, 95248, 95249, 96161 and 99113 with exp. dates between 2/28/09-5/31/12; Unit dose - Lots 102253, 76888, 76889, 81206, 81207, 81208 and 90491 with exp. dates between 6/31/10-6/31/12; 500-ct. bottles - Lots 67349, 67350, 73976, 75968, 77962, 77963, 81209, 81210, 84324, 84325, 87169, 89051, 89714, 89743, 90492, 90493, 90494, 90495, 90496, 90497, 90498, 90499, 92702, 92703, 92704, 92705 and 95251 with exp. dates between 1/31/09-5/31/10;

7) 100-ct. bottles - Lots 63468, 63469, 63470, 63471, 66029, 66030, 66031, 66032, 66033, 66034, 66035, 67351, 68107, 73758, 73982, 73983, 75270, 75346, 75970, 75971, 76700, 81218, 81219, 81220, 84289, 86294, 86510, 87529, 89745, 90500, 91584, 92709, 92710, 92711, 95253, 95254, 95255, 97922, 97923 and 97924 with exp. dates between 2/28/09-5/31/12; Unit dose - Lots 75972, 75973, 81221, 81223 and 93342 with exp. dates between 6/30/10-5/31/12; 500-ct. bottles - Lots 67353, 67354, 70607, 72566, 73984, 75974, 75975, 79287, 81737, 82307, 82308, 82309, 83926, 84326, 89085, 89747, 90509, 90510, 90511, 91588, 92713, 95256, 95257, 95258, 95259, 95260, 97925 and 97926 with exp. dates between 2/28/09-5/31/10;

8)Lots 62751, 62752, 66037, 66038, 67936, 67937, 72547, 73973, 73974, 75964, 75965, 81203, 81204, 81420, 83029, 84323, 89739, 89740, 89741, 89990, 89991, 90481, 90482, 90483, 91577, 91578, 91579, 91580, 92692, 92693, 92694, 92695, 92696, 92697, 92698, 95245, 95246, 96154, 96155, 96156 and 96157 with exp. dates between 3/31/09-4/30/12;

9) 100-ct. bottles - Lots 100925, 100926, 100927, 100928, 101581, 101582, 101583, 101584, 101585, 101586, 101587, 101588, 101589, 101590, 101591, 101592, 101593, 101594, 101595, 101596, 101597, 101598, 101599, 102178, 102179, 88984, 88985, 88986, 88987, 88988, 88989, 88990, 91163, 91164, 91165, 91166, 91167, 91169, 92794, 92795, 92796, 92797, 92798, 92799, 92800, 92801, 92802, 92803, 92804, 92805, 92806, 92807, 92808, 92809, 92810, 92811, 93021, 93022, 93023, 93024, 93025, 93026, 93027, 93028, 93029, 93030, 93031, 93032, 93033, 93034, 93035, 93036, 93037, 93038, 93039, 93040, 93041, 95911, 95912, 95914, 95915, 95916, 95917, 95918, 95920, 98870, 98873, 98874, 99656, 99657, 99658, 99659, 99660, 99661, 99662, 99663, 99664, 99665, 99666, 99667, 99668, 99683, 99684 and 99685 with exp. dates between 2/28/10-9/30/10; Unit dose - Lot 88991 and 93042 with exp. dates between 2/28/10-5/31/10; 1,000-ct. bottles. - Lots 87630, 87631, 88982, 88983, 91170, 91171, 91172, 92812, 92813, 92815, 92816, 92817, 92818, 92819, 92820, 92821, 92822, 92823, 92824, 93043, 93044, 93045, 93046, 93047, 93048, 93049, 93050, 93051, 93052, 95901, 95902, 95903, 95904, 95905, 95906, 95909, 95910, 96474 and 96475 with exp. dates between 2/28/10-9/30/10;

10) 100-ct. bottles - Lots 87632, 87633, 87634, 87635, 88327, 88328, 88329, 88993, 88994, 88995, 89794, 89795, 89796, 89797, 89798, 89799, 89800, 89801, 89802, 92825, 92826, 92827, 92828, 92829, 92830, 92831, 92832, 92833, 92834, 92835, 92836, 92837, 92838, 92839, 92840, 92841, 92842, 92843, 92844, 92845, 92846, 92847, 92848, 92849, 92850, 92851, 92852, 92853, 92857, 92858, 92859, 92860, 92861, 92862, 92863, 92865, 92866, 92867, 92868, 92869, 92870, 92871, 92872, 92873, 92874, 92875, 92876, 92877, 92878, 92879, 92880, 92881, 92882, 92883, 93053, 93054, 93055, 93056, 93057, 93058, 93059, 93060, 93061, 93062, 93063, 93064, 93065, 93066, 93067, 93068, 93069, 93070, 93071, 93072, 93073, 93074, 93075, 93076 ,93077, 93078, 93079, 93080, 93081, 93082, 93083, 93084, 93085, 93086, 93087, 93088, 93089, 93090, 93091, 93092, 93093, 93094, 93095, 93096, 93097, 93098, 93099, 93100, 93101, 93102, 93103, 93104, 93105, 93106, 93107, 93108, 93109, 93110, 93111, 93112, 93113, 93114, 93115, 93116, 93117, 93118, 93119, 93120, 93121, 93122, 93123, 93124, 93125, 93126 ,93127, 93128, 93129, 93131, 93132, 93133, 93134, 93135, 93136, 93137, 93138, 93139, 93140, 93141, 93142, 93143, 93144, 93145, 93146, 93147, 93148, 93149, 93150, 93151, 93152, 93153, 93154, 93155, 93159, 93160, 93161, 93162, 93163, 93164, 93165, 93166, 93167, 93168, 93169, 93170, 93171, 93172, 93173, 93174, 93176, 93180, 93181 and 93182 with exp. date between 12/31/09-8/31/10; Unit dose - Lots 87639, 87640, 92935, 93188 and 93189 with exp. date between 12/31/09-6/30/10; 1,000-ct. bottles - Lots 87636, 87637, 88331, 88332, 91162, 92917, 92918, 92919, 92920, 92921, 92922, 92923, 92924, 92925, 92926, 92927, 92928, 92929, 92930, 92931, 92932, 92933, 92934, 92950, 92951, 92952, 92953, 92955, 92956, 92957, 92958, 92959, 92960, 92961, 92962, 92963, 92964, 92965, 92966, 92967, 92968, 92969, 92970, 92971, 92972, 92973, 92974, 92976, 92977, 92978, 92979, 93190, 93191, 93192, 93193, 93194, 93195, 93196, 93197, 93198, 93199, 93200, 93201, 93202, 93203, 93204, 93205, 93206, 93207, 93208, 93209, 93210, 93211, 93212, 93213, 93214, 93215, 93216, 93217, 93218, 93219, 93220, 93221, 93222, 93223, 93224, 93225, 93226, 93227, 93228, 93229, 93230, 93231, 93232, 93233, 93234, 93235, 93236, 93238, 93239, 93240, 93241, 93242, 93243, 93244, 93245, 93246, 93247, 93248, 93249, 93250, 93251, 93252, 93253, 93254, 93255, 93256, 93257, 93258, 93259, 93260, 93262 and 93264 with exp. date between 1/31/10-8/31/10;

11) 100-ct. bottles - Lots 74257, 74262, 74282, 74283, 74284, 74285, 74286, 74287, 74288, 74289, 74290, 74291, 74292, 74293, 74294, 74295, 74296, 74314, 74315, 74316, 74317, 74318, 74320, 74321, 84515, 84516, 84517, 87641, 87642, 87643, 87644, 87646, 87647, 87648, 87998, 87999, 88000, 88067, 89005, 89006, 90383, 90384, 90385, 90386, 90387, 90388, 90389, 90390, 90391, 90392, 90393, 90394, 90395, 90396, 90397, 90398, 90399, 90400, 90401, 90402, 90403, 90404, 90405, 90406, 90407, 91139, 91140, 91141, 91142, 91143, 91144, 91145, 91146, 91147, 91148, 91149, 91150, 92603, 92604, 92605, 92606, 92607, 92608, 92609, 92610, 92620, 92621, 92622, 92623, 92624, 92625, 92626, 92627, 92628, 92629, 92630, 92631, 92632, 92633, 92634, 92936, 92937, 92938, 92939, 92940, 92941, 92942, 92943, 92944, 92945, 93568, 93569, 93570, 93571, 93572, 93573, 93574, 93575, 93576, 93577, 93578, 93579, 93580, 93581, 96450, 96451, 96452, 96453, 96454, 96455, 96456, 96457, 96458, 96459, 96460, 96461, 97322, 97323, 97324, 97325, 97326, 99551, 99552, 99553, 99554, 99555, 99556, 99557, 99558, 99559, 99560, 99561, 99562, 99564, with exp. dates between 5/31/09-8/31/10; Unit dose - Lots 74297, 84528 and 90863 with exp. dates between 7/31/09-11/30/09; 1,000-ct. bottles - Lots 87264, 87265, 87266, 87649, 87946, 88144, 88156, 88157, 88158, 89007, 89008, 89009, 89010, 89784, 89785, 89973, 89974, 89975, 89987, 89988, 89989, 89992, 89993, 90365, 90366, 90367, 90368, 90369, 90370, 90371, 90372, 90373, 90374, 90375, 90376, 90377, 90378, 90379, 90380, 90381, 90382, 90411, 90412, 90413, 90414, 90415, 90416, 90417, 90418, 90419, 90420, 90421, 90422, 90659, 90660, 90661, 90662, 90663, 90664, 90665, 90666, 90667, 90668, 90669, 90670, 90671, 90672, 90673, 91121, 91122, 91151, 91152, 91153, 91154, 91155, 91156, 91157, 91158, 93583, 93584, 93585, 93586, 93587, 93588, 93589, 93590, 93591, 93592, 93594, 93595, 93596, 93597, 93598, 96462, 96463, 96464, 96465, 97313, 97314, 97315, 97316, 97317, 97318, 97319, 97320, 97321, 98860, 98861, 98862, 99576, 99577, 99578, 99579, 99580, 99581, 99582, 99583, 99584, 99585, 99586, 99587 and 99588 with exp. dates between 7/31/09-6/30/10;

12) 100-ct. bottles - Lots 74298, 74299, 74300, 74301, 74302, 74303, 74304, 74305, 74306, 74307, 74308, 74309, 74310, 74311, 74312, 74313, 87651, 87652, 89011, 89012, 89039, 90027, 90028, 90029, 90865, 90866, 90867, 90868, 90869, 90871, 90872, 90873, 90874, 90875, 90876, 90877, 90879, 90880, 90881, 90882, 91159, 91160, 91161, 93599, 93600, 93601, 93602, 93603, 93604, 93605, 95540, 95541, 95542, 95543, 95544, 95545, 95867, 95868, 96466, 96467, 96468, 96469, 96470, 96471, 97272, 97273, 97274, 97275, 97276, 97277, 97278, 98809, 98810, 99645, 99646, 99647, 99648, 99650, 99651 and 99652 with exp. dates between 5/31/09-6/30/10; 1,000-ct. bottles - Lots 100287, 100646, 100647, 100648, 100649, 87669, 87670, 87944, 87945, 88078, 88160, 88199, 88311, 88357, 88912, 90018, 90019, 90020, 90021, 90022, 90025, 92614, 92916, 93606, 93607, 93608, 93609, 95191, 95702, 96473 and 99655 with exp. dates between 7/31/09-8/31/10;

13) Lots 82515, 82516, 89660, 89664, 89667, 90249, 90250, 90251, 91256, 91686, 91687, 91688, 91690, 91691, 91692, 93471, 96366, 96367, 96369, 96446, 97141, 97156, 97197, 97198, 97199 and 97208 with exp. dates between 3/31/09-9/30/10;

14) Lots 90253, 90254, 90255, 90256, 90257, 90258, 90259, 93284, 93472, 93473, 96372, 96373, 96374, 96375, 96376, 96377, 97160, 97215, 97917, 97918, 97919, 97920 and 97921 with exp. dates between 7/31/09-10/31/10;

15) Lots 86272, 86273, 86274, 86275, 86276, 87723, 87939, 88007, 89083, 89668, 89669, 89821, 90260, 90261, 90262, 90263, 90264, 90265, 90266, 90267, 90268, 90269, 90270, 90271, 90272, 91762, 91763, 91764, 91765, 91766, 91767, 91768, 91771, 91772, 93474, 93475, 93476, 93477, 93478, 93479, 93480, 93481, 93482, 93483, 93484, 93485, 93486, 95311, 95312, 95313, 95314, 95315, 95316, 95317, 95318, 98046, 98047, 98174, 98175, 98176, 98177, 98178, 98179, 98180, 98181, 98182, 98183, 98184, 98185, 98186, 98187, 98188, 99341, 99342, 99343, 99344, 99345, 99346, 99347, 99349, 99350, 99351, 99352, 99353, 99354 and 99355 with an exp. date between 4/30/09-11/30/10;

16) Lots 84790, 89670, 90248, 91684, 91685, 96363, 96364, 96365 and 99328 with an exp. date between 4/30/09-10/31/10;

17) Lots 84796, 88152, 89671, 91693, 96370 and 96371 with exp. dates between 6/30/09-9/30/10;

18) Lots 72692, 73836, 75384, 77852, 77853, 77854, 81746, 82519, 82520, 84113, 84668, 86423, 89089, 89090, 90273, 90274, 90275, 90276, 90277, 90278, 90279, 90280, 90281, 90282, 90283, 90284, 90285, 90286, 90287, 93487, 93488, 93489, 93490, 93491, 93492, 96380, 96381, 96382, 96383, 96384, 96385, 96386, 96387, 97163, 97164, 99672, 99673, 99674, 99675, 99676 and 99677 with exp. dates between 3/31/09-9/30/11;

19) Lots 71641, 71642, 72693, 72694, 75093, 75094, 77855, 77856, 77857, 77858, 82297, 82521, 82522, 83032, 86424, 87239, 88925, 90288, 90289, 90290, 90291, 90292, 90293, 90294, 90295, 90296, 90297, 90298, 93498, 95701, 96388, 96389, 96390, 96391, 96392, 96393, 96394, 96397, 97165, 97907, 97908, 97909, 97910, 97911, 97912, 97913, 97914 and 97915 with exp. dates between 1/31/09-10/31/11;

20) 100-ct. bottles - Lots 72279, 73761, 76925, 76926, 78184, 79373, 81241, 81242, 83470, 84357, 90525, 90526, 91636, 92792, 96310, 97927 and 98349 with exp. dates between 3/31/09-9/30/11; Unit dose - Lots 81240, 82323 and 97928 with exp. dates between 3/31/09-2/28/10;

21) Lots 71720, 74831, 76014, 76015, 81243, 81244, 81245, 89731, 90527, 90528, 90529, 90657, 91638, 91639, 91640, 95319, 96313, 96314, 97930, 97931, 99543 and 99544 with exp. dates between 3/31/09-11/30/11;

22) Lots 100440, 72834, 76016, 76017, 76018, 81246, 89092, 89732, 90530, 90532, 91641, 91642, 92793, 93739, 96315, 97932, 99547, 99548 and 99550 with exp. dates between 6/30/09-11/30/11;

23) Lots 81158, 82735, 83499, 84202, 85806, 87582, 88929, 88930, 89941, 89942, 91259, 91260, 91261, 91575, 91576, 92675, 92676, 93339, 93340, 95233, 96238, 96239, 96240, 96241, 97236 and 97237 with exp. dates between 2/28/09-11/30/11;

24) 100-ct. bottles - Lots 82259, 84197, 85823, 86477, 87203, 87575, 88910, 89947, 91253, 91254, 91255, 92663, 92664, 93321, 93742, 95215, 95216, 95218, 95219, 99043 and 99045 with exp. dates between 4/30/10-10/31/11; 500-ct. bottles - 82260, 82261, 84198, 86478, 86479, 87391, 89980, 89981, 91250, 92665, 92666 and 99047 with exp. dates between 4/30/09-10/31/10;

25) 100-ct. bottles - Lots 81118, 81149, 81150, 84199, 86302, 87577, 87578, 88004, 89945, 89946, 89982, 91572, 91573, 91574, 91622, 92391, 92392, 92667, 92668, 92669, 93322, 93323, 93324, 95220, 95221, 95222, 95223, 95224, 95225, 95226, 95227, 95228, 97219, 97220, 97221 and 97223 with exp. dates between 2/28/10-11/30/11; 500-ct. btls. - Lots 77961, 81151, 81152, 84200, 89681, 89983, 89984, 91251, 93522, 96232, 96233, 97226 and 97228 with exp. dates between 2/28/09-11/30/10;

26) 100-ct. bottles - Lots 75951, 80340, 81153, 84201, 86481, 87579, 87580, 87581, 89943, 89944, 91262, 91263, 91264, 91265, 91266, 91568, 91569, 92670, 92671, 93337, 93338, 95229, 95230, 95231, 95232, 96234, 96235, 97231, 97232, 97233, 97234 and 99055 with exp. dates between 2/28/09-10/31/11; 500-ct. bottles - Lots 80341, 81156, 81157, 81631, 86482, 87943, 89682, 89985, 89986, 91257, 91258, 92672, 92673, 92674, 93280, 93281, 97235 and 99062 with exp. dates between 4/30/09-10/31/10;

27) 100-ct. bottles - Lots 89058, 89059, 89060, 89611, 89613, 90056, 93306, 94645, 94646, 94647, 95145, 95146, 95951 and 95952 with exp. dates between 9/30/09-5/31/10; 500-ct. bottles - Lots 100424, 89057, 90058 and 94730 with exp. dates between 9/30/09-6/30/10 Unit dose cartons - Lots 89056 and 92643 with exp. dates between 11/30/09-3/31/10;

28) 100-ct. bottles - Lots 89054, 89055, 89402, 89614, 90059, 92644, 94900, 95147, 95148, 95150 and 95151 with exp. dates between 9/30/09-5/31/10;

29) Lots 72495, 76744, 76745, 79674, 81107, 81400, 83508, 83509, 84018, 84049 and 84903 with exp. dates between 3/31/09-11/30/10;

30) Lots 72496, 75843, 77930, 78185, 81108, 83510, 83511, 84050 and 84787 with exp. dates between 3/31/09-10/31/10;

31) 100-ct. bottles - Lots 79838, 81133, 89677 and 92662 with exp. dates between 4/30/09-10/31/09; 500-ct. bottles - Lots 75890, 75891, 86318, 97500, 98034, 98035, 98036, 98037 and 98038 with exp. dates between 1/31/09-2/28/10;

32) 100-ct. bottles - Lots 84068, 84069, 92661, 97493, 98020 and 98021 with exp. dates between 5/31/09-5/31/10; 500-ct. bottles - Lots 83500, 83501, 83502, 84070, 87574, 90080, 90086, 90087, 90088, 93311, 93312, 97495, 98022, 98023, 98024, 98025, 98026, 98027 and 99063 with exp. dates between 3/31/09-10/31/10;

33) 100-ct. bottles - Lots 79837, 81130, 84071, 86316, 98028 and 98029 with exp. dates between 2/28/09-3/31/10; 500-ct. bottles - Lots 75889, 81131, 81132, 84072, 88480, 90089, 93318, 96231, 98030 and 98031 with exp. dates between 2/28/09-5/31/10;

34) Lots 71637, 85545, 89676, 90060, 98049 and 98050 with exp. dates between 3/31/09-10/31/09;

35) 30-ct. bottles - Lots 83361, 87585, 89605, 91181, 92678 and 95234 with exp. dates between 2/28/09-5/31/10; 90-ct. bottles - Lots 101913, 79297, 79298, 79299, 84313, 87586, 89077, 89607, 90432, 90433, 90434, 92679, 92680, 92681, 95776, 95777 and 97238 with exp. dates between 1/30/09-7/31/10

36) 30-ct. bottles - Lots 83361, 87585, 89605, 91181, 92678 and 95234 with exp. dates between 1/31/09-5/31/10; 90-ct. bottles - Lots 101913, 79297, 79298, 79299, 84313, 87586, 89077, 89607, 90432, 90433, 90434, 92679, 92680, 92681, 95776, 95777 and 97238 with exp. dates between 1/31/09-5/31/10 Unit dose - Exp. date 2/28/09;

37) 30-ct. bottles - Lots 81557, 82270, 83923, 86492, 89612, 91184, 91186, 96140, 96243 and 98855 with exp. dates between 1/31/09-7/31/10; 90-ct. bottles - Lots 79326, 79327, 82271, 82272, 83355, 83356, 88997, 88998, 89615, 90439, 90440, 91187, 91188, 91189, 91190, 91191, 91192, 95239, 95240, 96244, 97241 and 97242 with exp. dates between 1/31/09-9/30/10; Unit dose - Lot 82266, Exp. date 3/31/09;

38) 30-ct. bottles - Lots 100117, 81559, 81634, 86493, 86494, 90441, 91193, 91194 and 91707 with exp. dates between 1/31/09-7/31/10; 90-ct. bottles - Lots 81636, 82288, 82289, 89000, 89917, 90442, 90443, 90444, 90445, 90446, 90448, 91195, 91196 and 91198 with exp. dates between 3/31/09-5/31/10;

39) 30-ct. bottles - Lots 83354, 86223, 86500, 87606, 89616, 89718, 89719, 91199, 91200, 96141, 96245 and 97245 with exp. dates between 3/31/09-5/31/10; 90-ct. bottles - Lots 81644, 82292, 82293, 82294, 84642, 87527, 87609, 87610, 89003, 89721, 89918, 90449, 90450, 90451, 90452, 90453, 90454, 90455, 90456, 90457, 90458, 90459, 90460, 90795, 91201, 91202, 91203, 91204, 91205, 91206, 96246, 96247, 96248 and 96249 with exp. dates between 3/31/09-5/31/10; Unit dose - Lots 82291 and 86496 with exp. dates between 3/31/09-7/31/09;

40) 30-ct. bottles - Lots 100449, 80536, 80540, 90461 and 96250 with exp. dates between 5/31/09-7/31/10; 90-ct. bottles - Lots 102251, 102252, 80538, 81649, 82295, 89723, 90462 and 96251 with exp. dates between 1/31/09-7/31/10;

41) Lots 72806, 72807, 75955, 76522, 80621, 81161, 83498, 84784, 89733, 90463, 92682, 92683, 96252 and 99068 with exp. dates between 7/2009-10/2011;

42) 100-ct. bottles - Lots 100224, 71707, 74028, 75956, 80517, 82298, 84203, 90464, and 97501, exp. dates between 3/31/09-5/31/11; 500-ct. bottles - Lots 100223, 71739, 75957, 82299, 84024, and 98959, exp. dates between 3/31/09-3/31/10;

43) 100-ct. bottles - Lots 69543, 73953,73954, 75958, 81189, 81190, 81191, 83496, 84314, 89734, and 98963, exp. dates between 1/31/09-12/31/10; 500-ct. bottles - Lots 100222, 73951, 73952, 75959, 82300, 83497, 89088, 94930, 97504, and 99034, exp. dates between 5/30/09-5/31/10;

44) 100-ct. bottles - Lots 73760, 73965, 73966, 75960, 76287, 81193, 81194, 81195, 84317, 86517, 87200, 87376, 87377, and 90471, exp. dates between 4/30/09-12/31/10; 500-ct. bottles - Lots 69241, 71740, 73967, 73968, 75961, 81196, 81197, 86504, 86505, 87007, 89737, 98968, 98969, and 98970, exp. dates between 1/31/09-1/31/10;

45) 100-ct. bottles - Lots 71709, 73969, 73970, 75962, 80518, 81630, 82301, 82302, 84319, 89738, 92689, 92690, and 99008, exp. dates between 5/31/09-4/30/11; 500-ct. bottles - Lots 71741, 73971, 73972, 75963, 81201, 81202, 84321, 90479, 90480, 92691, and 98085, exp. dates between 2/28/09-4/30/10;

46) Lots 100653, 101931, 76557, 76558, 79843, 82325, 82326, 84074, 84075, 89759, 91643, 96316, and 99073, exp. dates between 8/31/09-10/31/11;

47) 120-ct. bottles - Lots 102517, 76020, 82327, 82328, 86325, 90103, 91644, 96318, 98974, 99080, 99081, and 99624, exp. dates between 4/30/09-11/30/11; 1,000-ct. bottles - Lots 102516, 102683, 102984, 79848, 82329, 82330, 89760, 90104, 90105, 90579, 92884, 99074, 99075, 99076, 99077, 99078, 99079, 99622, and 99623, exp. dates between 4/30/09-11/31/11;

48) 120-ct. bottles - Lots 79849, 81275, 82331, 84077, 90106, 90107, 98081, 99087, 99626, and 99627, exp. dates between 3/31/09-10/31/11; 1,000-ct. bottles - Lots 77929, 81276, 81277, 84078, 89761, 89762, 96142, 99082, 99083, 99084, 99085, and 99086, exp. dates 3/30/09-10/31/11;

49) Lots 76639, 76644, 82379, 88163, 89650, 90169, 90170, 95158, and 96328, exp. dates between 4/30/09-8/31/10;

50) Lots 76258, 76259, 76264, 76634, 89649, 92900, and 99071, exp. dates between 3/31/09-10/31/11;

51) Lots 83155, 83156, and 83157, exp. dates between 1/31/09-2/28/09;

52) Lots 68676, 69627, 76525, 76527, 77919, 79885, 82360, 82361, 82362, 83337, 85772, 85773, 85774, 85775, 85776 86395, 86396, and 86397, exp. dates between 1/31/09-8/31/10;

53) Lots 77900, 79884, 82359, 84156, and 84157, exp. dates between 2/28/09-10/31/10;

54) 1-fl. oz. bottles - Lots 69770, 69771, 69772, 71717, 71718, 71719, 72267, 72268, 72269, 72270, 72271, 72273, 72830, 72831 72833, 73417, 73418, 74123, 74124, 74125, 74126, 74127, 74128, 76053, 76054, 76055, 76056, 76057, 76058, 76059, 76060, 76061, 76062, 76063, 76064, 81291, 81292, 82807, 82808, 84099, 86408, 86409, 86410, 86411, 90212 91666, 91667, 92981, 96143, 96144, and 99088, exp. dates between 1/31/09-11/30/11; 1-ml. ampoules - Lots 81923, 84097, 90213, and 92982, exp. dates between 6/30/09-4/30/10;

55) Lots 74001, 75845, 76267, 76268, 76269, 84051, 85547, exp. dates between 8/31/09-6/30/10;

56) Lots 79675, exp. 4/30/10; lots 81112, and 88146, exp. dates 6/30/10;

57) Lots 68070, 72820, 73928, 74003, 75850, 77931, 81113, and 83506, exp. dates between 1/31/09-4/30/10;

58) Lots 72520, 72686, 72687, 73909, 74002, 75848, 75849, 77957, 80469, 81115, 82549, 83507, 83924, 83969, 84257, 84258, 84670, 84699, 85550, 85551, 85965, and 87557, exp. dates between 2/28/09-7/31/11;

59) Lot 74004, Exp. 3/31/10;

60) Lots 83927, exp. 3/31/09; lots 84054 and 84055, exp. dates 5/31/09;

61) Lots 71639, 72688, 72689, 77932, 79676, 81116, 82546, 84056, 87460, 89082, 89956, and 90775, exp. dates between 3/31/09-2/28/11;

62) Lots 71732, 72859, 74005, 76288, 81117, 84057, 91552 and 91553, exp. dates between 2/28/09-2/28/11;

63) 16-fl. oz. bottles - Lots 69736, 69737, 69738, 69739, 69740, 69741, 69742, 71646, 71647, 71648, 71649, 71650, 71651, 71652, 71653, 71654, 71655, 71656, 71657, 71658, 71659, 71660, 71661, 72258, 72510, 74006, 74007, 75851, 75852, 75853, 75854, 75855, 77933, 77934, 77935, 77936, 77937, 77938, 77939, 77940, 77941, 77942, 77943, 80975, 80976, 80977, 80978, 80979, 80980, 80981, 80982, 80983, 80984, 85558, 85559, 85562, 85563, 85564, 85565, 85566, 85567, 85568, 85569, 85570, 85571, 85576, 85577, 85578, and 90839, exp. dates between 1/31/09-12/31/2010; 32-fl. oz. bottles - Lots 69744, 72860, 75856, 85589, and 88931, exp. dates between 1/31/09-11/30/10;

64) Lots 73929 and 74008, exp. date 8/31/09;

65) Lots 76065, 76066, 76067, 76068, 76069, 76070, 80967, 80968, 80969, 80970, 84100, 84101, 84102, 84103, 84104, 84105, 84106, 86415, 89872, 89873, 89874, 89875, 89876, 89877, 90214, 90215, 90216, 91668, 91669, 91670, 92384, 92983, 92984, 96337, 96338, 96339, 96340, 96341, 96342, 96343, 99091, 99092, 99093, 99094, and 99095, exp. dates between 1/31/09-10/31/10;

66) Lots 75868, 75869, 79681, 79682, 79683, 79684, 79685, 79686, 80985, 80986, 80987, 80988, 80989, 80990, 80991, 80992, 80993, 80994, 80995, 80996, 80997, 80998, 80999, and 81000, exp. dates 1/31/09-6/30/09;

67) Lots 72900, 82341, 82342, 82343, 83478, 84085, 86393, 89651, 89652, 90171, 90840, 92375, 92915, 95159, 99096, and 99097, exp. dates 2/28/09-10/31/10.

68) Lots 71643, 71644, 73843, 73844, 73845, 73846, 73847, 75073, 76647, 76648, 79878, 79879, 79880, 82344, 82345, 82346, 82347, 82348, 82349, 82350, 84086, 84087, and 89653, exp. dates between 3/31/09-12/31/10;

69) Lots 79881, 79882, 81063, 82351, 84089, 84090, 84091, 84092, 87689, and 87690, exp. dates 3/31/09-12/31/10;

70) Lot 71326, exp. date 4/30/09;

71) Lot 79677, exp. date 04/30/09; lot 84059, exp. date 09/30/09; and lot 88932, 02/28/10;

72) Lot 62351, exp. date 12/31/09;

73) Lot 75858, exp. date 8/31/09;

74) Lots 70545, 71246, 72829, 72861, 74012, 74013, 75859, and 75860, exp. dates between 2/28/09-7/31/10;

75) Lot 63829, exp. date 04/30/09; lot 69636, exp. date 08/31/09; and lot 76547, 08/31/09;

76) Lot 72862, exp. date 12/31/09;

77) Lot 72837, 74772, 75075, 75076, 77911, 77912, 82355, 82356, 84016, 99597, 99598, and 99614, exp. dates between 5/31/09-10/31/11;

78) Lots 69199, 72821, 74115, 77909, 81298, 81299, 82354, 83338, 84094, 88914, 89646, 89772, 90187, and 90188, exp. dates between 1/31/09-1/31/11;

79) Lots 72493, 72494, 77907, 77908, 80519, 81294, 81295, 82352, 82728, 89644, 90174, 90175, 90176 and 99606 with exp. dates between 02/28/2009 - 10/31/2009;

80) Lots 67917, 72701, 75074, 76681, 81296, 81297, 82353, 83918, 87698, 88459, 88911, 89162, 89181, 89645, 89771, 90177, 90178, 99594, 99608, 99609, 99610, 99611 and 99612 with exp. dates between 02/28/2009-09/30/2011;

81) Lots 72801, 75077, 77914, 79883, 81300, 82357, 82358, 88919, 89028, 89648, 90193, 99600, 99601, 99616 and 99617 with exp. dates between 04/30/2009 - 08/31/2011;

82) 100 count bottle - Lots 100967, 75978, 79272, 83619 and 84927 with exp. dates between 06/30/2009-05/31/2010. 500 count bottles - Lots 100968, 75985, 80516, 83494 and 84634 with exp. dates between 04/30/2009-05/31/2010, 1000 count bottles - Lots 80514, 80515 and 82311 with exp. dates between 06/30/2009-10/31/2009;

83) Lots 71804, 72683, 74832, 81924, 82513, 83534 and 84531 with exp. dates between 04/30/2009-11/30/2010;

84) 1/2 fl oz bottle - Lots 100384, 90230, 94805, 96168, 96356, 98039 and 98955 with exp. dates between 01/31/2010 - 10/31/2010. 1 fl oz bottle - Lots 80124, 80554, 80555, 80556, 80557, 80558, 80559, 80560, 80561, 80562, 81020, 81021, 81022, 81023, 81024, 81025, 81026, 81027, 81055, 81056, 81057, 83327, 83328, 83329, 83330, 83331, 83332, 83532, 83533, 84114, 84115, 84116, 84118, 84119, 84120, 84121, 90231, 90232, 90233, 90234, 90235, 90236, 90237, 90238, 90239, 91674, 91675, 91676, 91677, 91678, 91679, 91680, 95320, 95321, 95322, 96359, 96360, 96361, 96362, 97142, 97212, 97213, 97214, 99321, 99322, 99323 and 99324 with exp. dates between 01/31/2009 - 10/31/2011. 4 fl oz bottle - Lots 77860, 77861, 77862, 77863, 77864, 77865, 82426, 82427, 82523, 82524, 82525, 82526, 82527, 82528, 82529, 82530, 84122, 84123, 84124, 84125, 84126, 90240, 90241, 90242, 90243, 90244, 90245, 91682, 93469, 97153, 97155, 98041 and 98042 with exp. dates between 01/31/2009-11/30/2011. 8 fl oz bottles - Lots 77859, 80129, 82531, 84128, 84129, 84130, 84131, 84132, 90246, 90247, 91683 and 93470 with exp. dates between 03/31/2009-07/31/2011;

85) Lots 79665, 79666, 79667, 79668, 79669, 79670, 79671 and 83802 with exp. dates between 01/31/2009-07/31/2009;

86) Lots 82532, 82533, 82534, 86436, 91220 and 91221 with exp. dates between 01/31/2009-01/31/2010;

87) Lots 80502, 81228, 81229, 86521, 92785, 92786, 95113, 96295, 96296 and 99421 with exp. dates between 02/28/2009-10/31/2010;

88) 4 - 25 count bottles - Lots 82388, 82389, 82390, 82391, 82392, 82394, 82396, 82397, 82399, 82400, 82401, 82402, 82403, 82404, 82407, 82408, 84345, 84346, 84347, 84348, 84349, 84350, 89727, 89728, 89729, 90521, 90522, 90523, 90883, 90884, 90885, 90886, 91632, 91633, 91635, 92790, 92791, 95114, 96301, 96302, 96304, 96305, 96306, 96307, 99019, 99424 and 99425 with exp. dates between 02/28/2009-10/31/2010. 100 count bottles - Lots 76004, 81231, 81232, 81233, 81234, 81235, 81236, 83480, 83481, 83482, 83483, 83484, 83485, 83486, 89724, 89725, 89726, 90519, 90520, 92787, 92788, 92789, 94459, 94460, 96297, 96298, 96299 and 96300;

89) Lots 77966, 81237, 81238, 81239, 89730, 90524 and 96309 with exp. dates between 02/28/2010 - 07/31/2010;

90) Lots 82363, 82364, 83186, 83187, 83188, 88938, 89776, 89777, 89778, 89779, 89780, 89793, 89889, 89890, 89891, 89892, 89893, 89894, 90196, 90197, 90198, 90199, 90200, 90201, 91662, 96329, 96330, 96331, 98818, 99428, and 99429 with exp. dates between 01/31/2009-07/31/2010;

91) Lots 82365, 83192, 85299, 85300, 85302, 86400, 90202 and 94462 with exp. dates between 01/31/2009-02/28/2010;

92) Lots 83193, 84161, 85303, 85304, 85596, 85597, 85598, 85599, 85600, 86404, 86405, 86406, 88059, 89781, 89782, 90203, 90204, 90205, 90206, 94463, 94465, 94466, 99435 and 99436 with exp. dates between 01/31/2009-07/31/2010;

93) Lots 85851, 87192, 90207, 90208, 91663, 92178, 92179, 95267 and 96333 with exp. dates between 05/31/2009-10/31/2010;

94) 10 tablets - Lots 85852, 90209 and 93460 with exp. dates between 05/31/2009-03/31/2010. 30 tablets - Lots 85853, 87710, 88936, 90210, 91664 and 93461 with exp. dates between 05/31/2009-03/31/2010;

95) 100 capsule bottle - Lots 71300, 71301, 71302, 72819, 74150, 74151, 74152, 74153, 75101, 75102, 75103, 75104, 75105, 80194, 80195, 80196, 80197, 80198, 80199, 82729, 83620, 83621, 84138, 84667, 86437, 87469, 87470, 89046, 90319, 91516, 91517, 93499, 93500, 93501, 94467, 94468, 96398, 96399, 96400, 97169 and 97170 with exp. dates between 01/31/2009-11/30/2011. 10 - 10 blister packs - Lots 72840, 75106, 77866, 77867, 84134 and 91756 with exp. dates between 03/31/2009-06/30/2011;

96) 100 tablet bottle - Lots 76935, 76936, 77887, 77888, 77894, 77895, 77896, 89049, 89657, 89658, 89748, 89897, 90346, 90347, 90348, 90349, 90350, 90351, 90352, 90353, 90354, 90355, 90356, 90357, 90358, 90359, 90360, 90361, 90362, 90363, 90364, 93508, 93509, 93510, 93511, 96411, 96412, 96413, 96414, 96415, 96416, 96417, 96418, 96419, 96420, 96421, 97185, 97186, 97187, 97188, 97189, 97190, 97191, 97192, 97193, 97194, 97195, 97196, 97471, 97472, 97473, 97474, 97475, 97476, 97477, 97478, 97479, 99495, 99496, 99497, 99498, 99501 and 99502 with exp. dates between 04/30/2009-11/30/2010 10 -10 blister pack - Lots 82538, 84139, 84140, 89659, 90345, 93512 and 99511 with exp. dates between 04/30/2009-11/30/2010;

97) Lots 86438, 87741, 87742, 90320, 90321, 90322, 90323, 90324, 96186, 96187, 96188, 96189, 96190, 96191, 96192, 96193, 96194, 96195, 96196, 96197, 96198, 97453, 97454, 97455, 97456, 97457, 97458, 97459, 99443, 99444, 99445, 99446, 99447 and 99448 with exp. dates between 05/31/2009-11/31/2010;

98) Lots 80207, 80208, 80210, 80211, 80212, 80213, 80523, 90325, 90326, 90327, 90328, 90329, 90330, 90331, 90332, 93502, 93503, 93504, 93505, 95323, 95324, 96401, 96402, 96403, 96404, 96405, 96686, 96687, 96688, 96689, 96744, 96745, 96746, 96747, 96748, 96749, 96750, 96751, 96752, 96774, 96775, 96776, 96777, 96778 and 97463 with exp. dates between 02/28/2009-10/31/2010;

99) Lots 86441, 86442, 90333, 90334, 90335, 90336, 90337, 90338, 96406, 96407, 96408, 96410 and 97467 with exp. dates between 05/31/2009-11/31/2010;

100) Lots 77882, 77883, 77884, 89176, 90339, 90340, 90341, 90342, 90343, 90344, 90685, 93506, 93507, 95325, 95326, 96690, 96691, 96692, 96693, 96694, 96695, 96696, 96697, 96698, 96699, 96753, 96754, 96755, 96756, 96757, 96758, 96761, 96762, 96763, 96764, 96765, 96766, 96767, 96768, 96769, 96770, 96771 and 97177 with exp. dates between 01/31/2009-10/31/2010;

101) Lots 80343, 81278, 81279, 82332., 84079, 85766, 89763, 89939, 90108, 90109, 90110, 90111, 90112, 92885 and 92886 with exp. dates between 01/31/2009-09/30/2010;

102) Lots 81280, 81281, 81282, 84080, 84081, 89074, 89075, 90113, 90114, 90115, 90116, 90117, 90118, 90119, 92887, 92888, 92890, 99513 and 99515 with exp. dates between 02/28/2009-11/31/2010;

103) Lots 81284, 84019, 84614, 86382, 87168, 89764, 89765, 90120, 90121, 90122, 90123, 90124, 90125, 90126, 90127, 90128, 90129, 90130, 90131, 90132, 90133, 90134, 90135, 90136, 90137, 92891 and 92892 with exp. dates between 01/31/2009-09/30/2010;

104) Lots 82335, 83344, 89079, 89766, 89767, 90138, 90139, 90143, 90144, 90145, 90146, 90147, 90148, 99521 and 99522 with exp. dates between 07/31/2009-10/31/2010;

105) Lots 82336, 82337, 86383, 89768, 89769, 90150, 90151, 90152 and 96320 with exp. dates between 04/30/2009-10/31/2010;

106) Pangestyme UL12 - Lots 79852 and 90155 with exp. dates between 03/31/09-05/31/10;

107) Lots 79853 and 92895 with exp. dates between 03/31/09 -05/31/10;

108) Lots 82338, 84084, 85449, 90156, 90157 and 93445 with exp. dates between 05/31/2009-10/31/2010;

109) Lot 89787 with exp. date 07/31/2009;

110) Lot 74015, exp. date 06/30/2010;

111) Lots 83867, 84020, 84062, 84538, 85647, 85648, 86289, 86930, 89185, 89789, 89790, 89791, 90032, 90033, 90034 and 90035 with exp. dates between 02/28/2009- 11/30/2010;

112) Lot 75874, exp. date 06/30/10;

113) 100 tablet bottles - Lots 71730, 73764, 76042, 76043, 76044, 81289, 84777, 86386, 90159, 90160, 90161, 90162, 90163, 90164, 90165, 90901, 90902, 96199, 96200, 96201, 96202, 96203, 96204, 96323, 96324, 97964, 97965, 99528 and 99529 with exp. dates between 02/28/2009-10/31/2011. 500 tablet bottles - Lots 71731, 73765, 76045, 77918, 82339, 84778, 90166, 90167, 96325, 96326, 97966, 97967, 97968, 97969 and 99530 with exp. dates between 01/31/2009-09/30/2011;

114) 100 capsule bottle - Lots 98151 and 98152, exp. 09/30/2011 500 capsule bottle - Lot 98153, exp. date 09/30/11;

115) 100 capsule bottle - Lots 63825, 65019, 65020, 65021, 65022, 67899, 67900, 67901, 67902, 70775, 71600, 72708, 73754, 75986, 75987, 82312, 83861, 83921, 84330, 84537, 84781, 84909, 84910, 89070, 89752, 89753, 90030, 90031, 90635, 90636, 90637, 90638, 90639, 90641, 90642, 90643, 90644, 90645, 91589, 91590, 92714, 92715, 92716, 92717, 92718, 92719, 92720, 92721, 92722, 92723, 92724, 93272, 93523, 93524 and 96280 with exp. dates between 01/31/2009-06/30/2012. 500 capsule bottle - Lots 63933, 63934, 63935, 63936, 63937, 63938, 63939, 63940, 63941, 66404, 66405, 66406, 66407, 66408, 67732, 67737, 67738, 71803, 73520, 73705, 74113, 74803, 75994, 75995, 76552, 77114, 77192, 77980, 77981, 80402, 82216, 82314, 82315, 82316, 82317, 82476, 83345, 83346, 83347, 83348, 84340, 84341, 89071, 89072, 89073, 89755, 89756, 89757, 89758, 89970, 89972, 90603, 90604, 90605, 90606, 90607, 90608, 90609, 90610, 90611, 90612, 90613, 90614, 90615, 90616, 90617, 90618, 90619, 90620, 90621, 90622, 90623, 90624, 90625, 90626, 90627, 90628, 90629, 90630, 90631, 90632, 90633, 90634, 92737, 92738, 92739, 92740, 92741, 92742, 92743, 92744, 92745, 92746, 92747, 92748, 92749, 92750, 92751, 92752, 92753, 92754, 92755, 92756, 92757, 92758, 92759, 92760, 92761, 92762, 92763, 92764, 92765, 92767, 92769, 92770, 92771, 92772, 92773, 92774, 92775, 92776, 92777, 92778, 92779, 92780, 92781, 92782, 92783, 92784, 93548, 93549, 93550, 93551, 93552, 93553, 96286, 96287, 96288, 96289, 96290, 96291, 96292, 96293, 97992, 97993, 97994, 97995, 99129, 99130 and 99133 with exp. dates between 01/31/2009-06/30/2012. 1000 capsule bottles - Lots 102751, 102752, 102753, 65276, 65277, 65278, 65280, 65281, 65282, 65283, 65284, 65285, 65286, 65287, 67739, 67740, 67741, 67742, 67743, 67744, 67746, 69168, 71296, 72465, 72817, 73987, 73988, 74173, 74179, 75264, 75679, 75788, 75789, 75992, 75993, 81225, 81226, 82313, 84336, 84337, 84338, 84339, 84577, 84688, 86973, 87462, 87993, 89662, 89663, 89754, 89978, 90593, 90594, 90595, 90596, 90597, 90598, 90599, 90600, 90601, 90602, 91591, 91592, 91593, 91594, 91595, 92725, 92726, 92727, 92728, 92729, 92730, 92731, 92732, 92733, 92734, 92735, 92736, 93528, 93529, 93530, 93531, 93532, 93533, 93534, 93535, 93536, 93537, 93538, 93539, 93540, 93541, 93542, 93543, 93544, 93545, 93546, 93547, 94809, 94810, 94811, 94812, 94813, 94814, 94815, 94816, 94817, 94818, 94819, 94820, 94821, 94822, 94823, 94824, 94825, 94826, 94827, 94828, 94829, 94830, 94831, 94832, 94833, 94834, 94835, 94836, 94837, 96810, 96811, 96812, 96813, 96814, 96815, 96816, 96817, 96818, 96819, 96820, 96821, 96822, 96823, 96824, 99318, 99319 and 99320 with exp. dates between 02/28/2009-10/31/2012 Unit Dose Blister Pack - Lots 69716, 69717, 72818, 75293, 75294, 75295, 75296, 75297, 75989, 75990, 75991, 76631, 84331, 84332, 84333, 90589, 90590 and 92768 with exp. dates between 04/30/2009-10/31/2012;

116) Lots 83350, 83351, 83352, 83353, 84928, 84929, 84930, 89749, 90513, 90514, 90515, 91180, 94456 and 94458 with exp. dates between 04/30/2009-02/28/2010;

117) Lots 101346, 101347, 101348, 101350, 101351, 83920, 84166, 84167, 84168, 84578, 84579, 84580, 84581, 84582, 84583, 84584, 84607, 84608, 84609, 84610, 84611, 85592, 85682, 85683, 85684, 85686, 85687, 85693, 90047, 90048, 90049, 90050, 90051, 90052, 90053, 90054, 90055, 90779, 90780, 90781, 90782, 90783, 90784, 92641, 92642, 93303, 93304, 93305, 96181, 99533 and 99534 with exp. dates between 03/31/2009-12/31/2010;

118) Lots 101568, 77817, 81372, 81373, 82366, 82367, 82368, 82369, 82370, 82371, 82372, 89672, 89673, 89674, 89675, 90777, 90778, 91554, 94452, 96179, 98808 and 99532 with exp. dates between 02/28/09-11/30/10;

119) 8 oz bottle - 80013, 80014, 88943 and 94453 with exp. dates between 02/28/09 -11/30/09 16 oz bottle - 77925, 77926, 77927, 77928, 81010, 81011, 81012, 81013, 92640 and 95950 with exp. dates between 02/28/2009-05/31/2010;

120) Lots 83503, 83917, 84065, 84066, 85950, 85951, 86312, 87170, 87212, 87243, 87244, 87479, 87480 and 90074 with exp. dates between 01/31/2010 - 11/30/2010;

121) Lots 71697, 73930, 74018 and 81124 with exp. dates between 01/31/2009-05/31/2010;

122) Lots 71696, 73931, 73932 and 75876 with exp. dates between 01/31/09-05/31/10;

123) Lots 74021 and 81128 with exp. dates between 01/31/2009-09/30/2010;

124) Lots 72865, 74022, 77944, 81009 and 90078 with exp. dates between 09/30/2009-02/28/2011;
125) Lots 72698, 72866 and 72867 with exp. dates between 05/31/09 -06/30/09;

126) X;

127) X;

128) Lots 80339, 82376, 82377, 86457, 86511, 89631 and 90533 with exp. dates between 03/31/2009-02/28/2010;

129) Lots 77203 and 89632 with exp. dates 06/30/2009 and 01/31/2010;

130) Lot 98892, exp. date 06/30/2010;

131) Lot 98893, exp. date 07/31/2010;

132) Lots 92527, 92528, 92529, 92530, 92531 and 95269 with exp. dates 02/25/2010 - 06/30/2010;

133) Lots 83298, 84181, 84182, 84183 and 91138 with exp. dates 02/28/09 and 01/31/10;

134) Lots 90428, 90429, 90431, 92677, 93341, 95705 and 98082 with exp. dates between 01/31/2010 - 01/31/2011;

135) Lot 98689, exp. date 04/30/2011;

136) Lots 72846, 73840, 75083, 80025, 82375, 84169, 90211 and 91665 with exp. dates 06/30/2009-06/30/2011;

137) Lot 100381, exp. date 09/30/2010;

138) Lots 81539, 81540, 90547 and 93516 with exp. dates between 01/31/2009-09/30/2010;

139) Lots 80337, 82384, 82385, 90534 and 90535 with exp. dates between 05/31/2009 - 04/30/2010;

140) Lots 83297, 85786, 90546, 93514 and 95162 with exp. dates 05/31/2009 - 07/31/2010;

141) Lots 77214, 77215, 93513 and 95273 with exp. dates between 01/31/2009-10/31/2010;

142) Lots 82398, 83026, 83289, 84170, 84698, 85677, 85925, 86283, 86462, 86463, 86464, 87245, 87752, 89048, 89061, 89638, 90039, 90040, 90041, 90042, 90537, 90538, 90539, 90540, 90541, 90542, 90543, 91742, 91743, 94652, 95271, 96430, 96431, 96432, 96433, 99360, 99361, 99362 and 99363 with exp. dates between 02/28/2009-11/30/2010;

143) Lots 82405, 91475 and 96480 with exp. dates between 06/30/2009-06/30/2010;

144) Lots 77805, 81538, 89639 and 93515 with exp. dates between 02/28/2009-01/31/2010

145) Lots 75113, 81542, 81543, 90548 and 91745 with exp. dates between 03/31/2009-05/31/2010;

146) Lots 82410, 82411, 82540, 82547, 86284, 89640, 90549, 90550 and 90551 with exp. dates between 03/31/2009-06/30/2010;

147) Lots 81545, 81546, 82548, 83467, 89641, 90553 and 91747 with exp. dates between 01/31/2009-02/28/2010;

148) Lots 76737 and 93518 with exp. dates 06/30/2009 and 06/30/2011;

149) Lots 71604, 73677, 73678, 77830, 77831, 81547, 81548, 83323, 86471, 90554 and 93520 with exp. dates between 01/31/2009-05/31/2011;

150) Lots 64966, 73679, 73831, 77832, 80338, 81549, 81550 and 83829 with exp. dates between 02/28/2009-06/30/2010;

151) 100 tablet bottles - Lots 82415, 82416, 83912, 84175, 84176, 86473, 87190, 87759, 87908, 89081, 89642, 91695, 91749, 91750, 91751, 95275, 95276, 95278, 95279 and 95280 with exp. dates between 03/31/2009-05/31/2010 Unit dose packs - Lots 82417, 82418, 84177, 84178 and 91752 with exp. dates between 03/31/2009-01/31/2010;

152) Lots 82421, 82422, 82763, 91753, 91754, 95189, 96948 and 97490 with exp. dates between 04/30/2009-09/30/2010;

153) Lots 81028, 85549, 86475, 89643 and 91755 with exp. dates between 01/31/2009-08/31/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethex Corp., Bridgeton MO, by press release and letters on January 28, 2009 and on February 3, 2009.
Manufacturer: KV Pharmaceutical Co Westport, Saint Louis, MO. Firm initiated recall is ongoing.
REASON
The products were not made in conformance with GMP's
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT 
a) Chromagen Caplet, Rx, an oral iron supplement packaged in 90 caplet bottles. MNDC 64011-198-26, Recall # D-242-2009;

b) Chromagen FA caplet, , Rx. an oral iron supplement packaged in 90 caplet bottles. NDC 64011-199-26, Recall # D-243-2009; 

c) Chromagen Forte caplet, Rx, an oral iron supplement packaged in 90 caplet bottles, NDC 64011-197-26, Recall # D-244-2009;

d) Encora capsule/tablet, each carton contains 30 capsules and 30 tablets packaged in individual blisters, NDC 64011-166-36, Rx. Recall # D-245-2009;

e) Niferex Gold tablet, iron supplement, Rx. packaged in 90 tablet bottles. NDC 64011-162-26, Recall # D-246-2009;

f) Niferex 150 Forte Capsule, Rx, packaged in 90 capsule bottles. NDC 64011-164-26, D-247-2009;

g) PreCare Chewable tablet, packaged in 30 tablet bottles, Rx. NDC 64011-024-19, D-248-2009;

h) PreCare Premier tablet, packaged in 30 caplet bottles, Rx. NDC 64011-195-19, Recall # D-249-2009;

i) PreCare Conceive tablet, packaged in 30 tablet bottles, Rx. NDC 64011-014-19, Recall # D-250-2009;

j) PremesisRx tablet, packaged in 30 tablet bottles, Rx. NDC 64011-019-19, Recall # D-251-2009;

k) PrimaCare capsule/tablet, each carton contains 30 capsules and 30 tablets packaged in individual blisters, Rx. NDC 64011-204-28, Recall # D-252-2009; 

l) PrimaCare Advantage capsule/tablet, each carton contains 30 capsules and 30 tablets packaged in individual blisters, NDC 64011-230-28, Rx, Recall # D-253-2009;

m) PrimaCare ONE capsule, packaged in 30 capsule bottles, Rx. NDC 64011-200-19, Recall # D-254-2009;  

n) PrimaCare ONE capsule, , packaged in 30 capsule bottles, Rx. NDC 6401-218-19, Recall # D-255-2009;  

o) Repliva 21/7 tablet, packaged in 28 day tablet pack (21 active, 7 absorption period tablets) Rx. NDC 64011-0207-34, Recall # D-256-2009 
CODE
a) Lots 102981, 80927, 80928, 80929, 80930, 82767, 90806, 91520, 94674, 97328 and 99870 with exp. dates between 2/28/09-10/31/10;

b) Lots 75803, 75804, 80924, 82768, 90037 and 93558 with exp. dates between 2/28/09-10/31/10;  

c) Lots 80920, 80921, 80922, 80923, 81753, 84033, 90807, 93557 and 99871 with exp. dates between 2/28/09-7/31/10;

d) Lots 80880, 80881, 89630, 89805, 89806, 89807, 90805, 91518, 93555, 93556, 95283, 99733 and 99734 with exp. dates between 3/31/09-6/30/10;

e) Lots 81085, 81754, 83270, 83271, 86346, 90038 and 98294 with Exp. dates between 3/31/09-6/30/10;

f) Lots 75820, 75821, 80949, 89707, 89977, 90809, 96949 and 96950 with exp. dates between 4/30/09-7/31/10;

g) Lots 102494, 82792, 82793, 82794, 90810 and 94679 with exp. dates between 4/30/09-5/31/10;

h) Lots 75826, 75827, 76051, 76546, 79697, 90006, 91544, 91545, 94680, 95301, 96354, 98813, 98814 and 99026 with exp. dates between 2/28/09-11/30/10;

i) Lots 100950, 73817, 75824 and 90811 with exp. dates between 5/31/09-2/28/11;

j) Lots 76457, 81097, 81098, 83283 and 88992 with exp. dates between 2/28/09-1/31/10;

k) Lots 80913, 80914, 80915, 82809, 82810, 84940, 91487, 94865, 95119, 95120, 95121 and 96639 with exp. dates between 2/28/09-4/30/10;

l) Lots 91419, 91537 and 91538 with exp. dates between 1/31/10-3/31/10;

m) Lots 80891, 80892, 84035, 85927, 86268, 89708, 90674, 90675, 90676, 90677, 90678, 90812, 90813, 91546, 91547, 94681, 94682, 94683, 94778, 94779, 94780, 94781, 94782, 94783, 94784, 94785, 94786, 94787, 94788, 94789, 94790, 94792, 94793, 94794, 94795, 94796, 95302, 95303, 95304, 95305, 95306, 95309, 95310, 96481 and 96482 with exp. dates 2/28/09-03/31/10;

n) Lots 100300, 100301, 100302, 100307, 100308, 100309, 98003, 98004 and 98008 with exp. dates between 7/31/10-9/30/10;

o) Lots 84879, 84880, 84881, 84882, 84883, 84884, 84885, 84886, 84887, 84888, 84889, 84890, 84891, 84893, 84894, 84895, 84896, 84897, 86347, 86348, 86349, 86350, 86351, 86352, 86353, 86354, 86355, 86356, 86357, 91524, 91525, 91526, 91527, 91528, 91529, 91530, 96490, 96491, 96492 and 96493 with exp. dates between 5/31/09-3/31/10
 RECALLING FIRM/MANUFACTURER
Recalling Firm: Ther-Rx Corp., Bridgeton, MO, By press release and letter on January 28, 2009 an additional press release and letter dated February 3, 2009.
Manufacturer: KV Pharmaceutical Co Westport, Saint Louis, MO. Firm initiated recall is ongoing.
REASON
The products were not manufactured in conformance with GMP's
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide and countries of Indonesia, Singapore, Switzerland, Hungary, Canada, Brazil, Australia

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0724-09
CODE
Unit: 17FX96401 (split unit)
RECALLING FIRM/MANUFACTURER
The American National Red Cross, North Central Region, Saint Paul, MN, by facsimile on May 19, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled in a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MN
___________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0725-09;
b) Fresh Frozen Plasma, Recall # B-0726-09
CODE
a) and b) Units: 55L67840 and 55S58124
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, by telephone on January 16, 2008 and facsimile on January 17, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
AR, OK, TN
___________________________________
PRODUCT 
Cryoprecipitated AHF, Recall # B-0738-09
CODE
Units: 0392938, 0338566, 0392951, 0392945, 0339544, 0392936, 0338548, 0392935, 0395688, 0338577, 0338554
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on October 11, 2007 and by letter on October 17, 2007. Firm initiated recall is complete.
REASON
Blood products, which were not manufactured in accordance to current Good Manufacturing Practices, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
LA, AL
___________________________________
PRODUCT 
Cryoprecipitated AHF, Recall # B-0740-09
CODE
Units: 0355154, 0402207, 0409669, 0403795, 0405760, 0402211, 0355537, 0409667, 0406140, 0403532, 0403785
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on October 11, 2007 and by letter on October 17, 2007. Firm initiated recall is complete.
REASON
Blood products, which were not manufactured in accordance to current Good Manufacturing Practices, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
LA
___________________________________
PRODUCT 
Source Plasma, Recall # B-0820-09
CODE
Units: TQ058060, TQ057525
RECALLING FIRM/MANUFACTURER
IBBI dba Knoxville Plasma Corp., Knoxville, TN, by fax on January 7, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-0821-09
CODE
Units: 08KWIB1576, 08KWIB1537
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank, Inc., WI, Kenosha, WI, by fax on January 3, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0827-09;
b) Fresh Frozen Plasma, Recall # B-0828-09
CODE
a) and b) Units: 72J504140
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on December 29, 2008. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0829-09
CODE
Unit: 032KK90891
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by telephone and by letter dated December 4, 2008. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0831-09
CODE
Unit: 032KW09601
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by facsimile and by letter dated January 10, 2009. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT 
Source Plasma, Recall # B-0832-09
CODE
Units: 08KWIB8683, 08KWIB7552, 08KWIB7387
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank, Inc. WI, Kenosha, WI, by facsimile on January 15, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who lived in an area considered at risk for HIV-Group O, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
Source Plasma, Recall # B-0833-09
CODE
Units: 2080234758, 2080230887, 2080230638, 2080229690, 2080229080
RECALLING FIRM/MANUFACTURER
PlasmaCare, Inc., Cincinnati, OH, by fax on January 17, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0834-09
CODE
Unit: 6381867
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on December 5, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0835-09
CODE
Unit: 06LM61189
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by telephone and/or email on December 11, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from donors whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0837-09
CODE
Unit: W036908920610
RECALLING FIRM/MANUFACTURER
Blood Bank of Delmarva, Inc., Newark, DE, by letter dated February 2, 2009. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed..
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
D.C.
___________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0838-09;
b) Plasma Frozen, Recall # B-0839-09
CODE
a) and b) Unit: GS07216
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by fax on December 15, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the drug Avodart, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0840-09
CODE
Unit: 2357279
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter dated December 10, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-0841-09
CODE
Units: 9855886, 5758683
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by email on January 5, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland

___________________________________
PRODUCT 
a) Recovered Plasma, Recall # B-0842-09;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0843-09
CODE
a) and b) Unit: 2143727
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shrewsbury, NJ, by fax on December 5 and December 10, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had ear piercing within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland, NJ
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0850-09
CODE
Unit: W038609790013 (2 units)
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Inc., Sarasota, FL, by telephone on February 4, 2009. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0852-09
CODE
Unit: 72J228743
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Mobile, AL, by facsimile on December 12, 2008.
Manufacturer: LifeSouth Community Blood Centers, Inc., Gainesville, FL. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0853-09
CODE
Unit: W071208029912
RECALLING FIRM/MANUFACTURER
Medic Inc., Knoxville, TN, by letter dated December 9, 2008. Firm initiated recall is complete.
REASON
Blood product, for which the sample used for nucleic acid testing (NAT) was unsuitable, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0854-09;
b) Fresh Frozen Plasma, Recall # B-0855-09
CODE
a) and b) Unit: 6197201
RECALLING FIRM/MANUFACTURER
HemaCare Corp., Van Nuys, CA, by telephone on March 9, 2009 and by letter dated March 11, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who may have received a body piercing within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0856-09;
b) Recovered Plasma, Recall # B-0857-09
CODE
a) Units: 7298318, 7223170, 5213640, 7186173, 7196347;
b) Units: 7298318 (2 units), 7223170, 7186173, 7196347
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N Goldman Center, Oklahoma City, OK, by facsimile on November 5, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from deferred donors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
IN, CA, NY, AR, OK
___________________________________
PRODUCT 
Source Plasma, Recall # B-0858-09
CODE
Units: 365034037, 365032343, 365032013, 365031401, 365031109, 365030591, 365028480, 365028308, 365025572, 365025242, 365023649, 365023213, 365022725, 365013613, 365012487, 365011464, 365010982, 365010373, 365009722, 365009059, 365008769, 365006673, 365006323, 365005670, 365004817, 365000081
RECALLING FIRM/MANUFACTURER
Telecris Plasma Resources, Roanoke, VA, by fax on October 9, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had been incarcerated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
26 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
a) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0859-09;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-0860-09
CODE
a) Units: 029KQ00678, 029KQ00723;
b) Units: 029KQ00967, 029KQ00966 (part 1 and 2), 029KQ00723, 029KQ00677, 029KQ00678
RECALLING FIRM/MANUFACTURER
American National Red Cross, Mid Atlantic Region, Norfolk, VA, by telephone on November 9, 2006 and by letter dated November 16, 2006. Firm initiated recall is complete.
REASON
Blood products, for which the sterility may have been compromised, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
VA, NC
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0861-09
CODE
Units: 53FN27027, 53G89453, 53H36870, 53LY09795
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone on November 22, 2007 followed by a letter dated December 28, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported living in a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MD, D.C.
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0862-09;
CODE
Unit: 53FN22447
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone and email on May 29, 2007 followed by a letter dated June 13, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0865-09
CODE
Unit: W050908046476
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by letter dated January 16, 2009. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________
PRODUCT 
Cornea, Recall # B-0624-09
CODE
Unit: 05040801, 05040802
RECALLING FIRM/MANUFACTURER
Northeast Pa Lions Eye Bank, Inc., Allentown, PA, by letters dated October 13, 2008. Firm initiated recall is complete.
REASON
Human corneal tissues, recovered from a donor more than seven days after collection of the blood sample to determine donor eligibility, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 corneas
DISTRIBUTION
PA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0752-09
CODE
Unit: W087608560751
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA, by letter dated August 18, 2008 and by fax on August 20, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 component
DISTRIBUTION
VA, Vienna, Austria
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0766-09
CODE
Unit: W040709470042
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN, by telephone on March 20, 2009. Firm initiated recall is complete.
REASON
Blood product, labeled with an incorrect weight, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0770-09
CODE
Unit: 4182013
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN, by telephone on November 20, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0804-09
CODE
Units: W127808202579, W127808202298, W127808200964, W127808200106, W127808202703
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA, by letter dated February 27, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was using a non-steroidal anti-inflammatory drug (NSAID) at the time of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
WA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0826-09
CODE
Unit: F94479
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by facsimile on September 25, 2008. Firm initiated recall is complete.
REASON
Blood product, which was leukoreduced past the maximum allowable time after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0830-09
CODE
Unit: W0397080351215
RECALLING FIRM/MANUFACTURER
Recalling Firm: Heartland Blood Centers, Aurora, IL, by letter dated January 2, 2009.
Manufacturer: Heartland Blood Centers, Tinley Park, Tinley Park, IL. Firm initiated recall is complete.
REASON
Blood product, which may have been out of controlled storage for greater than 30 minutes during irradiation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-0836-09
CODE
Unit: 06LM61189
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by telephone and/or email on December 11, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from donors whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA 
___________________________________
PRODUCT 
a) Platelets, Recall # B-0844-09;
b) Red Blood Cells, Recall # B-0845-09
CODE
a) and b) Unit: F49606
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by fax on December 16, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the medication Bactrim, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland, MI
___________________________________
PRODUCT 
Fresh Frozen Plasma, Recall # B-0848-09
CODE
Unit: W0352082638510
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on January 22, 2009 and by letter on February 13, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0849-09
CODE
Unit: W036509028294
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA, by telephone on February 11, 2009 and by facsimile on February 26, 2009. Firm initiated recall is complete.
REASON
Blood product, which was a low volume unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT 
Platelets, Recall # B-0851-09
CODE
Unit: W227709380102
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by facsimile on February 13, 2009. Firm initiated recall is complete.
REASON
Blood product collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-0863-09
CODE
Unit: 53FN22447
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone and email on May 29, 2007 followed by a letter dated June 13, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________
PRODUCT 
a) Stryker PainPump2, 250 mL PainPump with Luer Lock Tubing Set, 2.5 inch ExFen and Standard Catheter, 5 per box, sterile; REF 525-125. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management, Recall # Z-1182-2009;

b) Stryker PainPump2, 250 mL PainPump with Luer Lock Tubing Set, 5.0 inch ExFen and Standard Catheter, 5 per box, sterile; REF 525-155. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management, Recall # Z-1183-2009;

c) Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen Catheter and Luer Lock Tubing Set, 5 per box, sterile; REF 525-158. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management, Recall # Z-1184-2009;

d) Stryker PainPump2, 250 mL PainPump with Luer Lock Tubing Set, 5 per box, sterile; REF 525-350. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management, Recall # Z-1185-2009;

e) Stryker PainPump2, 400 mL PainPump with 2.5 inch ExFen 2 Site Catheter Set, 5 per box, sterile; REF 540-25. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management. Recall # Z-1186-2009;

f) Stryker PainPump2, 400 mL PainPump with 5.0 inch ExFen 2 Site Catheter Set, 5 per box, sterile; REF 540-50. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management, Recall # Z-1187-2009;

g) Stryker PainPump2, 400 mL PainPump with Luer Lock Tubing Set, 5.0 inch ExFen and Standard Catheter, 5 per box, sterile; REF 540-155. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management, Recall # Z-1188-2009;

h) Stryker PainPump2, 250 mL Pre-Set PainPump with Luer Lock Tubing Set, 2.5 inch ExFen and Standard Catheter, 5 per box, sterile; REF 521-125. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management, Recall # Z-1189-2009;

i) Stryker PainPump2, 250 mL Pre-Set PainPump with Luer Lock Tubing Set, 5.0 inch ExFen and Standard Catheter, 5 per box, sterile; REF 521-155. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management, Recall # Z-1190-2009;

j) Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen 2-Site Catheter Set, 5 per box, sterile; REF 525-25. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management. Recall # Z-1191-2009;

k) Stryker PainPump2, 250 mL PainPump with 5.0 inch ExFen 2-Site Catheter Set, 5 per box, sterile; REF 525-50. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management, Recall # Z-1192-2009;

l) Stryker PainPump2, 400 mL PainPump with Luer Lock Tubing Set, 5 per box, sterile, REF 540-350. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management, Recall # Z-1193-2009;

m) Stryker PainPump2, 400 mL PainPump with Luer Lock Tubing Set, 5.0 inch ExFen and Standard Catheter, 5 per box, sterile; REF 541-155. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management, Recall # Z-1194-2009
CODE
a) Lot Numbers: 08228012, 08240012, 08248012, 08259012, 08269012, 08277012, 08323012 and 08324012;

b) Lot Numbers: 08228012, 08236012, 08249012, 08259012, 08268022, 08271012, 08273022, 08297012, 08315022, 08323012, 08324012 and 08344012;

c) Lot Number: 08316012

d) Lot Numbers: 08255012 and 08343012;

e) Lot Numbers: 08239012, 08254012 and 08297012;

f) Lot Numbers: 08227012, 08239012, 08255012, 08275012, 08291012, 08296012 and 08304012;

g) Lot Numbers: 08227012, 08242012, 08260012, 08274012, 08275012, 08276012, 08296012, 08301012, 08304012, 08311012 and 08317012;

h) Lot Numbers: 08248012, 08269012, 08276012, 08280012, 08281012, 08322012 and 08325012;

i) Lot Numbers: 08240012, 08260012, 08270012, 08274012, 08280012, 08318012 and 08325012;

j) Lot Numbers: 08229012, 08240012, 08269012 and 08316012;

k) Lot Numbers: 08228012, 08240012, 08255012, 08270012 and 08277012;

l) Lot Numbers: 08239012, 08242012, 08254012, 08270012, 08271012, 08280012, 08281012, 08282012, 08283012, 08287012, 08288012, 08289012, 08290012, 08298012, 08301012, 08302012, 08303012, 08306012, 08308022, 08310012, 08311012, 08317012, 08318012, 08329022, 08330012, 08331012, 08336022, 08337022, 08339012, 08340012, 08343022 and 08345012;

m) Lot Numbers: 08239012, 08242012, 08260012, 08274012 and 08291012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Instruments Div. of Stryker Corp, Portage, MI, by letter dated February 11, 2009.
Manufacturer: Stryker Puerto Rico, Inc, Arroyo, PR. Firm initiated recall is ongoing. 
REASON
An electronic failure during preparation of the unit, or during patient use, may cause the pump to shut down.
VOLUME OF PRODUCT IN COMMERCE
25 pumps
DISTRIBUTION
Nationwide and countries of Argentina, Australia, Brazil, Canada, England, Singapore and South Africa
___________________________________
PRODUCT
Beckman Coulter Access Immunoassay System Hybritech PSA Calibrators, Product Number: 37205. The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems, Recall # Z-1197-2009
CODE
Lot Numbers: 715292 and 722462
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc, Brea, CA, by letter dated January 10, 2008.
Manufacturer: Beckman Coulter Inc, Fullerton, CA. Firm initiated recall is complete.
REASON
Beckman Coulter incorrectly shipped Access Hybritech PSA calibrators containing dual calibration cards (Hybritech and WHO) to some Access Hybritech PSA Customers. The WHO calibration for PSA is not currently approved in the United States.
VOLUME OF PRODUCT IN COMMERCE
123 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Screwdriver for 3.5mm Screws, DARCO system, instrument for use in orthopedic implant surgery. REF: DC4261, Non-sterile, Rx only, 1 each, Recall # Z-1208-2009
CODE
Lot numbers: 019598209, 038504328, 058486628, 058507733, 058516752, 067422530, 088538652, 098538652, 107439501, 107442247, 117442247, 0712180, S0701050
RECALLING FIRM/MANUFACTURER
Wright Medical Technology Inc, Arlington, TN, by letters on March 11, 2009. Firm initiated recall is ongoing.  
REASON
The package insert lists 3 sterilization procedures, 2 of which are not validated. Pre-vacuum steam sterilization is validated.
VOLUME OF PRODUCT IN COMMERCE
682 devices
DISTRIBUTION
Nationwide and Canada, Germany, France, Belgium, the Netherlands, Italy, Finland, Austria, Denmark, Norway, Turkey, South Africa, United Kingdom, and Australia
___________________________________
PRODUCT 
Dentsply, MAILLEFER, CYTCO-K TITANIUM POST SYSTEM, dental implant components, Model numbers (SKU): C106KL0050A20 (12 posts) and C117K00000020 (4 posts), Swiss Made, Recall # Z-1234-2009
CODE
C106KL0050A20 (12 posts), Packing Lot Numbers: 2045470, 2457580, 2725900, 2918670, 3032820, 3174500, 3328470, 3626480, and 3779590 C117K00000020 (4 posts), Packing Lot Numbers: 2660790, 3076090, 3231740, and 3797230
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dentsply Worldwide Headqrt, York PA, by letter and e-mail on March 20, 2009
Manufacturer: Maillefer Instruments Holding SA, Ballaigues, Switzerland. Firm initiated recall is ongoing.
REASON
The product is manufactured with a left-hand thread instead of a right hand thread. This error could cause tooth breakage if the posts were removed without knowing that the threads were reversed.
VOLUME OF PRODUCT IN COMMERCE
1588 posts
DISTRIBUTION
Nationwide and countries of Canada, Germany, France, Holland, Switzerland, The Netherlands, Italy, Kuwait, Poland, Argentina, Greece, Russia, Czech Republic, Belgium, Turkey, Hungary, India, and Colombia
___________________________________
PRODUCT 
Syngo Imaging, picture archiving and communications system (PACS), Model number 10 014 063, Recall # Z-1235-2009 
CODE
Serial numbers: 1005, 1039, 1040, 1041, 1043, 1049, 1053, 1055, 1056, 1057, 1058, 1061, 1064, 1065, 1067, 1071, 1074, 1076, 1079, 1080, 1081, 1082, 1083, 1084, 1086, 1090, 1105, 1107, 1112, 1114, 1116, 1119, 1124, 1174, 1188, 1189, 1202, 1203, 1210, 1218, 1226, 1227, 1229, 1240, 1246, 1247, 1258, 1269, 1271, 1278, 1279, 1310, 1316, 1329, and 1334 
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc, Malvern PA, by visit in November 2008.
Manufacturer: Siemens Ag Healthcare Sector, Erlangen, Germany. Firm initiated recall is ongoing.
REASON
Incorrect and/or incomplete data: Several potential safety issues while working with the syngo Image product including, but not limited to, data loss, errors in patient data due to different patient IDs, delays in image availability, inaccurate results during image measurements, incorrect review or diagnosis of displayed or printed images, measurement inaccuracies from the host modality and image scaling problems prior to system calibration and alignment.
VOLUME OF PRODUCT IN COMMERCE
55 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT 
Cerner Bridge Medical Transfusion Administration and Specimen Collections, Recall # Z-1236-2009
CODE
Software Versions 3.4.0, 3.4.1 and 3.4.2.
RECALLING FIRM/MANUFACTURER
Cerner Corp, Kansas City, MO, by letter dated January 15, 2009. Firm initiated recall is ongoing.
REASON
Specimen labels printing incorrect patient demographics.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
OH, NC, MO and MI
___________________________________
PRODUCT
Alaris Patient-Controlled Analgesia (PCA) Module (formerly Medley PCA Module) Model 8120 used with the Alaris PC Unit with software versions 8 through 9.1. Recall # Z-1237-2009
CODE
Serial Numbers: 000000000003692805, 000000000002326369 to 000000000012892953.
RECALLING FIRM/MANUFACTURER
Cardinal Health 303 dba Cardinal Health, San Diego, CA, by letter on March 11, 2009. Firm initiated recall is ongoing.
REASON
The Alaris PCA module can potentially infuse above or below the intended infusion dose.
VOLUME OF PRODUCT IN COMMERCE
164,000 units
DISTRIBUTION
Nationwide, Canada, Germany, Malaysia, and Singapore
___________________________________
PRODUCT
syngo Imaging model number 10014063. Affected systems are V30A or earlier with an NFS connected archive and V30A systems where image data was stored to LTS using software version older than V30A. Picture Archiving and communications system. Recall # Z-1266-2009
CODE
Serial numbers: 1279, 1210, 1246, 1198, 1105, 1227, 1064, 1058, 1083, 1090, 1189, 1061, 1258, 1119, 1039, 1040, 1074, 1079, 1282 and 1056
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc, Malvern, PA, by letter dated 02/09/2009.
Manufacturer: Siemens Ag Healthcare Sector, Erlangen, Germany. Firm initiated recall is ongoing.
REASON
An issue concerning archived image data that is sporadically saved with corrupted data may occur. This issue may occur when syngo Imaging is configured to archive image data on a network file system (NFS) connected via a connected archive (Mount Point Solution).
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
AL, CA, CT, FL, LA, MI, MO, NC, NJ, OH, PA, TN, and WI
___________________________________
PRODUCT
Lumi 8 Intense LED Light Facial System, Mode of Operation: Operation with Intermittent/continuous load, Visible and Invisible LED Radiation, Class 3R LED Product, Refer to IEC 60825-2001 for further information., Input: 100 -230 V AC 50/60 HZ Power Input: 1509 V A....Protective Eyewear required Wavelength 590 & 630 nm. Recall # Z-1308-2009
CODE
Serial Number 170401
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sybaritic, Inc, Bloomington, MN, by letter and telephone on June 18, 2008.
Manufacturer: Beijing Top Laser Tech Co., Ltd, Beijing, China. Firm initiated recall is ongoing.  
REASON
Sybaritic stated that no 510(k) has been filed for the device (Lumi 8 Intense LED Light Facial System). No injuries or illness reported.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Hill-Rom TotalCare Bed, Model P1900. The TotalCare (R) Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare (R) Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post. Recall # Z-1317-2009
CODE
Serial numbers from J329AM1149 through J339AM1343
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letter dated March 9, 2009. Firm initiated recall is ongoing.
REASON
An e-ring may not have been installed during production, which could result in an inability to latch the siderail.
VOLUME OF PRODUCT IN COMMERCE
53 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
a) Tri-State Centurion Endoscopy Tray, sterile, 10 per case; Reorder MNS4635. Recall # 1319;

b) Tri-State Centurion Laceration Tray - SnagFree, sterile, 16 per case; Reorder SUT12265. Recall # Z-1320;

c) Tri-State Centurion Incision and Drainage Tray, sterile, 20 per case; Reorder ID615. Recall # Z-1321;

d) Tri-State Centurion Plastic Laceration Set, sterile, 16 per case; Reorder SUT3390. Recall # Z-1322
CODE
a) and b) Lot Number: 2008111050;
c) Lot Number: 2008111450;
d) Lot Number: 2008111750
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tri-State Hospital Supply Corp, Howell, MI, by letter dated January 14, 2009.
Manufacturer: Tri-State Hospital Supply Corp, Salisbury, NC. Firm initiated recall is ongoing.
REASON
Compromised sterility, as the package seals may be inadequate.
VOLUME OF PRODUCT IN COMMERCE
550 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  VETENERARY - CLASS II

___________________________________
PRODUCT 
a)  American Nutrition Vita Bone Flavors Large Dog Treats, 48 oz box, UPC 012623 734804, Recall # V-139-2009;

b) American Nutrition Vita Bone Flavors Medium Dog Treats, 24 oz box, UPC 012623 732411, Recall # V-140-2009;

c) American Nutrition Vita Bone Flavors Small Dog Treats, 24 oz box, UPC 012623 732404, Recall # V-141-2009;

d) American Nutrition Vita Snacks Peanut Butter, 3 oz plastic bag, UPC 012623 813158, Recall # V-142-2009;

e) Farm Style Small Assorted Dog Biscuits, 5 lb plastic bag, UPC 078601 902054, Recall # V-143-2009;

f) Hill Country Fare Small 5 Flavor Dog Biscuits, 4 lb plastic bag, UPC 041220 520800, V-144-2009;

g) Hill Country Fare Small Peanut Butter Dog Biscuits, 4 lb plastic bag, UPC 041220 175383, Recall # V-145-2009;

h) Integrity Small Assorted Dog Biscuits, 4 lb plastic bag, UPC 064237 146398, Recall # V-146-2009;

i) Northwest Royal Small Dog Biscuits Assorted Flavors, 5 lb plastic bag, UPC 071357 003372, Recall # V-147-2009;

j) Mill Creek Premium Large Assorted Dog Biscuits, 20 lb box, UPC 078601 951069, Recall # V-148-2009;

k) Mill Creek Premium Small Assorted Dog Biscuits, 20 lb box, UPC 078601 951052, Recall # V-149-2009;

l) Premium Smarty Dog Biscuits Assorted Flavors Small, 4 lb plastic bag, UPC 041512 046094, Recall # V-150-2009;

m) Springfield Prize Multi-Flavor Dog Biscuits, 26 oz box, UPC 041380 141693,
Recall # V-151-2009;

n) Springfield Prize Multi-Flavor Dog Biscuits, 4 lb plastic bag, UPC 041380 139652, Recall # V-152-2009;

o) Western Family Biscuits Multi-Flavor, 10 lb box, UPC015400 062299, Recall # V-153-2009;

p) Western Family Biscuits Multi-Flavor, 4 lb plastic bag, UPC 015400 064088,
Recall # V-154-2009;

q) Western Family Biscuits Multi-Flavor, 18 oz box, UPC 015400 038867, Recall # V-155-2009;

r) Next Gen Pet Products Small Assorted Biscuits, 30 lb box, Recall # V-156-2009;

s) Small Assorted Dog Biscuits-Bulk, 25 lb box, Recall # V-157-2009;

t) Western Family (Canada only) Small Dog Biscuits 4 Assorted Flavors, 2 kg plastic bag, UPC 062639 295851, Recall # V-158-2009;

u) Yeaster Small Assorted, 30 lb box, Recall # V-159-2009
CODE
a) - i) All dates prior to 01/18/10;
j) - k) Lot codes: 001A7xxx to 018A9xxx;
l) – q) All dates prior to JAN 18 10;
r) – s) Lot codes: 001A7xxx to 018A9xxx;
t) All dates prior to 01/18/10;
u) Lot codes: 0017A7xxx to 018A9xxx
RECALLING FIRM/MANUFACTURER
American Nutrition, Inc., Ogden, UT, by a press release on February 10, 2009. Firm initiated recall is ongoing.
REASON
Dog treats were made from peanut product being recalled by PCA because of possible Salmonella contamination.
VOLUME OF PRODUCT IN COMMERCE
106,555 cases
DISTRIBUTION
Nationwide and Canada

END OF ENFORCEMENT REPORT FOR MAY 6, 2009

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