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U.S. Department of Health and Human Services

Safety

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Enforcement Report for September 2, 2009

September 2, 2009
09-35

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

___________________________________
PRODUCT 
1) Dry Roasted Peanuts, Roasted and Unsalted Blanched Sold as the following: 1) 1 lb plastic bag and 5/1 lb unit. 1 lb bag labeled in part; and 2) 10 and 25 lb bulk plastic heat-sealed cellophane flatpacks labeled in part, UPC 0 32491 20701 9, Recall # F-955-9;

2) Dry Roasted Peanuts Roasted and Salted Blanched. Product sold as: 1) 1 lb plastic bag and 3/1 lb unit. 1 lb bag labeled in part. 3 lb bag may be labeled in part, UPC 0 32491 20703 3 and 2) 25 lb bulk plastic heat-sealed cellophane flatpacks labeled in part, UPC 0 32491 20703 3, Recall # F-956-9;

3) Fiesta Mix, A Blend of Sweet Crunchy and Salty. Product sold as: 1) 1 lb plastic bags, 3/1 lb and 5/1 lb units. 1 lb bags labeled in part, 3 lb bags may be labeled in part, UPC 0 32491 20859 7; and 2) 10 lb and 25 lb bulk plastic heat-sealed cellophane flatpacks labeled in part, UPC 0 32491 20859 7, Recall # F-957-9;

4) Toasted Diced Peanuts Roasted and Unsalted Diced Peanuts; 25 lb bulk plastic heat-sealed cellophane flatpacks labeled in part, UPC 0 32491 20336 3; Recall # F-958-9;

5) Honey Roasted Peanuts, Peanuts Coated in Honey Batter. Product sold as: 1) 1 lb plastic bag, 3/1 lb unit, d 5/1 lb unit, and 3 lb jar. 1 lb bag labeled in part; 3 lb bag and jar may be labeled in part, UPC 0 32491 20584 8; and 2) 10 lb and 25 lb bulk plastic heat-sealed cellophane flatpacks labeled in part, UPC 0 32491 20584 8; Recall # F-959-9;

6) Roca Toffee Toffee, Nuts, Chocolate; 1 lb plastic package or 1 lb decorative tin labeled in part, Recall # F-960-9;

7) Raw Redskin Peanuts; product sold as, 1) 1 lb plastic bag; and 2) 5 lb, 10 lb, 15 lb, 20 lb and 25 lb bulk clear plastic bag labeled in part, UPC 0 32491 20705 7, Recall # F-961-9;

8) Raw Spanish Peanuts; product sold as, 1) 1 lb plastic bag labeled in part; and 2) 5 lb, 10 lb, 15 lb, 20 lb and 25 lb bulk clear plastic bag labeled in part, UPC 0 32491 20711 8, Recall # F-962-9;

9) Raw Blanched Peanuts; product sold as, 1) 1 lb plastic bag; and 2) 5 lb, 10 lb, 15 lb, 20 lb and 25 lb bulk clear plastic bag, UPC 0 32491 20692 0, Recall # F-963-9;

10) Toasted Diced Peanuts, Roasted and Unsalted; product sold as, 1) 1 lb plastic bag and 2) 5 lb, 10 lb, 15 lb, 20 lb, 25 lb and 30 lb bulk clear plastic bag, UPC 0 32491 20336 3, Recall # F-964-9
CODE
There are no manufacturing codes or Use By dates.
RECALLING FIRM/MANUFACTURER
Premier Packing Co. d.b.a. The Nut Factory, Greenacres, WA, by telephone, letter and press release on February 13, 2009 and February 17, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using peanut products recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
8,245 lbs
DISTRIBUTION
AK, CA, ID, MT, NV, OR, TX and WA
___________________________________
PRODUCT 
Bulk Peanut Butter made from organic dry roasted split peanuts using self-serve grinder equipment provided by the retail stores. There is no standardized package or product label; the customer may bring his/her own package or use plastic tubs provided by the store, Recall # F-965-9
CODE
Sold Before February 3, 2009
RECALLING FIRM/MANUFACTURER
New Seasons Market, Portland, OR, by store posting and website on February 2, 2009 and press release on February 12, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using peanut products recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
36,290 lbs
DISTRIBUTION
OR
___________________________________
PRODUCT 
Popcorn Breader, packaged 50 pound bags, item #FA353501, and labeled in part ***KFC Popcorn Breader***For manufacturing and professional use only, Recall # F-966-9
CODE
Lot #: 5061396416 5061396417 5061396418 5061396419 5061396421 5061396422 5061396402 5061396403 5061396420 5061396423 5061396401 5061396404 5061396405 5061396406 5061396407 5061396408 5061396409 5061396410 5061396411 5061396412 5061396413 5061396414 5061396415 5061396424 5061396426 5061396427 5061396425 5061396428 5061396429 5061396430 5061396431 5061396432 5061396433 5061396434 5063473319 5063473320 5063473322 5063473323 5063473324 5063473325 5063473326 5063473327 5063473328 5063473329 5063473321 5063473301 5063473302 5063473303 5063473304 5063473305 5063473306 5063473307 5063473308 5063473309 5063473310 5063473311 5063473312 5063473313 5063473314 5063473315 5063473316 5063473317 5063473318 5063473330 5064959101 5064959102 5064959103 5064959104 5064959105 5064959106 5064959107 5064959108 5064959109 5064959110 5064959111 5064959112 5064959113 5064959114 5064959115 5064959116 5064959117 5064959118 5064959119 5064959120 5064959121 5064959122 5064959123 5064959124 5064959125
RECALLING FIRM/MANUFACTURER
McCormick & Company, Inc., USIG HQ, Hunt Valley, MD, by letter on June 25, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using an ingredient recalled by Plainview Milk Products because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
209,400 pounds
DISTRIBUTION
AR
___________________________________
PRODUCT 
1) Something Better Carob Coated Peanuts in 3.5 pound, 1 pound, 12 ounce and 8 ounce packages, no UPC, Recall # F-967-9;

2) Something Better Carob Coated Peanut Clusters in 3.5 pound and 12 ounce packages, no UPC, Recall # F-968-9; 

3) Something Better Carob Coated Fruit & Nut Clusters in 3.5 pound, 1 pound and 12 ounce packages, no UPC, Recall # F-969-9; 

4) Something Better Carob Coated Mixed Nuts in 3.5 pound, 1 pound and 8 ounce packages, no UPC, Recall # F-970-9;

5) Something Better Carob Coated Bridge Mix in 1 pound and 8 ounce packages, no UPC, Recall # F-971-9; 

6) Something Better Honey Nut Granola in 2 pound packages, no UPC, Recall # F-972-9;

7) Something Better 5-Grain Granola in 2 pound packages, no UPC, Recall # F-973-9; 
CODE
All lot numbers that end with number 8 plus any lot numbers that contain the Code Q88 or Q89
RECALLING FIRM/MANUFACTURER
Recalling Firm: Something Better Natural Foods, Battle Creek, MI, by letter dated February 4, 2009 and by press release on February 11, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using peanut products recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,925 pounds
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Haven’s Candies brand Mix Chocolate Peanut Clusters, 4 lb stock boxes, corrugated box, Recall # F-974-9;
2) Haven’s Candies brand Dark Chocolate Peanut Clusters, 4 lb stock boxes, corrugated box, Recall # F-975-9
CODE
1) Milk Run Dates: 11/10/08, 12/16/08, 12/29/08, 1/26/09, 2/2/09;
2) Dark Run Dates: 12/2/08, 2/4/09, 2/19/09;
RECALLING FIRM/MANUFACTURER
Haven’s Candies, Westbrook, ME, by telephone on March 5, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanut products recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
60 pounds
DISTRIBUTION
ME, MA, NH, CT, NY
___________________________________
PRODUCT 
Nutraceuticals Apple Cinnamon Oatmeal Mix Powder 773 grams, Recall # F-976-9
CODE
Lot number: 21704, exp 7/2010
RECALLING FIRM/MANUFACTURER
United National Labs, Inc., Milroy, PA, by letter dated July 16, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using an ingredient recalled by Plainview Milk Products because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,999 bottles
DISTRIBUTION
CA and Russia
___________________________________
PRODUCT 
1) NW Delights Dark Chocolate Olympic Classic Trail Mix is sold as follows: (1) 11 oz Dark Chocolate Olympic Classic Trail Mix packaged into cellophane bags with UPC 0 15953 70013. (2) 14 oz Dark Chocolate Olympic Classic Trail Mix packaged into cellophane bags with UPC 0 15953 70042. Label on the 11 oz and 14 oz packages read "NW Delights DARK CHOCOLATE OLYMPIC CLASSIC***". 11 oz and 14 oz packed 12 per case. (3) Bulk 25 lb Dark Chocolate Olympic Classic Trail Mix, Recall # F-977-9;

2) NW Delights Nooksack Trail Mix are sold as follows: (1) 11 oz Nooksack Trail Mix packaged into cellophane bags with UPC 0 15953 70030 and labeled in part, "NW Delights ALL NATURAL NOOKSACK TRAIL MIX". Packaged 12 per case. (2) Bulk 25 lb Nooksack Trail Mix packaged into a cardboard box with a plastic liner with UPC 0 15953 70130, Recall # F-978-9;

3) NW Delights Olympia Trail Mix sold as follows: (1) 11 oz Olympia Trail Mix packaged into cellophane bags with UPC 0 15953 70006 and labeled in part, "NW Delights ALL NATURAL OLYMPIA TRAIL MIX". Packaged 12 per case. (2) Bulk 25 lb Olympia Trail Mix packaged into a cardboard box with a plastic liner with UPC 0 15953 70106, Recall # F-979-9;

4) NW Delights Pacific Crest Trail Mix sold as follows: (1) 10 oz Pacific Crest Trail Mix packaged into cellophane bags with UPC 0 15953 70029 and labeled in part, "NW Delights ALL NATURAL PACIFIC CREST MIX***", Packaged 12 per case. (2) Bulk 10 lb Pacific Crest Trail Mix packaged into a cardboard box with a plastic liner with UPC 0 15953 70429. (3) Bulk 25 lb Pacific Crest Trail Mix packaged into a cardboard box with a plastic liner with UPC 0 15953 70129, Recall # F-980-9;

5) Northwest Delights Cascade Trail Mix, bulk 25 lb case packaged in a cardboard box with a plastic liner, UPC 0 15953 70105, Recall # F-981-9;

6) NW Delights San Juan Trail Mix sold as follows: (1) 9 oz San Juan Trail Mix packaged into cellophane bags with UPC 0 15953 70022 and labeled in part, (2) Bulk 25 lb case San Juan Trail Mix packaged into a cardboard box with a plastic liner, Recall # F-982-9;

7) NW Delights Milk Chocolate Peanut Clusters, 9 oz plastic tub with a lid, UPC 0 15953 70914, packed 6 per case, Recall # F-983-9;
CODE
1) 11 oz and 14 oz package: Best By dates between 04/08/09 and 04/28/09; 2) Lot codes: a) 11 oz - Lot code 08115; b) 14 oz - Lot codes 08099 and 08115; c) 25 lb bulk case - Lot codes 08099 and 08112 (Lot code is Julian Date - 08112 = April 21, 2008);

2) 1) 11 oz package: Best by date between 4/08/09 and 4/28/09; Lot code 08119. 2) 25 lb bulk case: Best by date between 03/10/09 and 04/22/09; Lot codes 08070 and 08113 (Lot code is Julian Date - 08113 = April 22, 2008);

3) 1) 11 oz package - Best by date between 04/08/09 and 04/28/09; Lot Code 08116. 2) Bulk 25 lb case - Best by date between 03/07/09 and 04/18/09; Lot codes 08067, 08074, and 08109 (Lot code is Julian Date - 08112 = April 21, 2008);

4) 1) 10 oz package - Best by date between 04/08/09 and 04/28/09; Lot code 08116. 2) Bulk 10 lb case - Best by date of 4/11/09; lot code 08102. 3) Bulk 25 lb case - Best by date of 04/22/09; Lot code 08113 (Lot code is Julian Date - 08113 = April 22, 2008);

5) Best by date between 03/12/09 and 04/21/09; Lot codes 08072, 08100, and 08112 (Lot code is Julian Date - 08112 = April 21, 2008);

6) 1) 9 oz package - Best by date on or before 05/09/09; Lot codes 08067 and 08130. 2) bulk 25 lb case - Best by date on or before May 1, 2009; Lot codes 08122 and 08086 (Lot code is Julian Date - 08112 = April 21, 2008);

7) Expiration date 02/27/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Natures World LLC, Sumner, WA, by e-mail on January 29, 2009, press release on February 18, 2009 and March 17, 2009, and by telephone, e-mail and visit on March 16, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
33,181.75 pounds
DISTRIBUTION
AK, WA, ID, MT, OR, CA, HI
___________________________________
PRODUCT 
Mighty-O Organic Nutty Vanilla Donut. Standard-sized donut with glaze and topped with chopped peanuts; 104 gram Net Wt. Product has no packaging, UPC code and is not labeled. Product sold in 2 lb boxes to customers for individual sale in display case. A sign may be present at the point of sale which reads in part, "Mighty-O Donuts, the organic donut, certified organic ingredients, dairy and egg free, trans-fat free, locally owned." Recall # F-984-9
CODE
None
RECALLING FIRM/MANUFACTURER
Mighty O Donuts, Seattle, WA, by e-mail and telephone on February 12, 2009, by press release on February 19, 2009 and by press release and e-mail on March 11, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanut products recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
67,807 dozen
DISTRIBUTION
WA
___________________________________
PRODUCT 
Paley Bar Jam'n Peanuts sold as individual Net wt. 2 oz (57 g) bars (UPC 8 97426 00002 4) and in 12-bar boxes (UPC 8 97426 00012 3). Individual bar wrapper reads in part, Recall # F-985-9
CODE
Best by dates: 23 July 2009, 18 March 2009, 23 January 2008, 23 March 2008, 28 June 2008, 29 August 2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Paley’s Inc., Portland, OR, by telephone, e-mail, and letter dated March 2, 2009, by press release on March 7, 2009 and by telephone on March 25, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanut products recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
6,566 – 2 oz bars
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Potent Life Bittersweet Cacao Crunch. Sold as: 1) individual 40 g (1.4 oz) bar in plastic package with UPC 8 54674 00106 7 and labeled in part, 2) 12-count boxes with box UPC 8 54674 00110 4, Recall # F-986-9;

2) Potent Life Whole Goji Berry. Sold as: 1) individual 40 g (1.4 oz) bar in plastic package with UPC 8 54674 00107 4 and labeled in part, 2) 12-count boxes with UPC 8 54674 00111 1, Recall # F-987-9;

3) Potent Life Himalayan Pink Salty Peanuts. Sold as: 1) individual 40 g (1.4 oz) bar in plastic package with UPC 8 54674 00108 1 and labeled in part, 2) 12-count boxes with UPC 8 54674 00112 8, Recall # F-988-9;

4) Potent Life Cherry Chocolate. Sold as: 1) individual 40 g (1.4 oz) bar in plastic package with UPC 8 54674 00109 8 and labeled in part, 2) 12-count boxes with UPC 8 54674 00113 5, Recall # F-989-9;

5) Boku Super Bar- Organic Chocolate Chip, sold as Individual 40 g (1.4oz ) Bars in plastic package with UPC 8 95028 00204 0, Recall # F-990-9
CODE
Affected products identified by the following BEST BY dates: BEST BY 31JAN 08, BEST BY 25MAR 09 and BEST BY 21MAY 09;
RECALLING FIRM/MANUFACTURER
Recalling Firm: Potent Foods, Inc., Portland, OR, by telephone and letter dated March 3, 2009 and press release on March 5, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
22,968 bars
DISTRIBUTION
Nationwide, Canada and Denmark

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT 
25 mcg, NDC 60793-116-01, Cytomel, Liothyronine Sodium Tablets, 100 Tablets, Rx only, Recall # D-1895-2009
CODE
Lot numbers: 52215, exp 09/2009 and 52216, exp 09/2009
RECALLING FIRM/MANUFACTURER
King Pharmaceuticals, Inc., Bristol, TN, by letter on August 6, 2009. Firm initiated recall is ongoing.
REASON
Subpotent 12 month stability time point.
VOLUME OF PRODUCT IN COMMERCE
47,400 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Actavis Twice a Day buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets NDC 67767-133-60, Recall # D-1896-2009
CODE
Lot number: 0805699A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Actavis South Atlantic LLC, Sunrise FL, by letter on June 23, 2009.
Manufacturer: Catalent Pharma Solutions LLC, Winchester, KY. Firm initiated recall is ongoing.
REASON
Failed Impurity Specification: m-chlorobenzoic acid.
VOLUME OF PRODUCT IN COMMERCE
13,236 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Midazolam HCl, Cherry Syrup, 2MG/ML CIV 5ml, Mfg. ROX, NDC 00054-3566-99, Recall # D-1899-2009; 

2) Tussionex Clll, Hydrocodone/Chlorphin, 5ML, 1/8mg/5ml, ER SUSP, Mfg. UCB, Recall # D-1900-2009;

3) Midazolam HCl, Oral Syrup, 5ML, 2MG/ML CIV, Mfg. ROX, Recall # D-1901-2009;

4) Tussionex Clll, Hydrocodone/Chlorphn, 10/8MG/5ML, ER SUSP, 5ML, Mfg. UCB, NDC 53014-0548-67, Recall # D-1902-2009;

5) LEVOTHYROXINE sub: SYNTHROID, 125MCG TAB, Mfg LAN, NDC 00527-1347-01, Recall # D-1903-2009;

6) NAPROXEN SOD, 220MG CAP, Mfg. GDL, NDC 00182-1106-19, Recall # D-1904-2009;

7) TANDEM PLUS, IRON COMPLEX CAP, Mfg. USP, NDC 52747-0902-60, Recall # D-1905-2009;

8) ERYTHROMYCIN D-R, sub: ERYC, 250MG CAP, Mfg. ABB, NDC 00074-6301-13, Recall # D-1906-2009;

9) HYDROXYZINE HCl sub: ATARAX 50MG TAB, Mfg. KVK, NDC 10702-0012-01, Recall # D-1907-2009;

10) GUIAFEN PE, GUIAFEN/PHYLPHRINE 800-25MG TAB, Mfg. BRK, NDC 51991-0428-01, Recall # D-1908-2009;

11) CARDENE SR, NICARDIPINE HCl SR 45MG CAP, Mfg. EPH, NDC 67286-0813-04, Recall # D-1909-2009;

12) PRECOSE, ACARBOSE 25MG TAB, Mfg. BAY, NDC 00026-2863-51, Recall # D-1910-2009;

13) STRESS W/ZINC, MV STRESS FORM W/Zn TAB, Mfg. GDL, NDC 00182-4491-26, Recall # D-1911-2009;

14) VITAMIN E 400 IU CAP, Mfg. N-B, NDC 74312-0023-40, Recall # D-1912-2009;

15) ZYRTEC OTC, CETIRIZINE HCl 10MG TAB, Mfg MCN, NDC 50580-0726-38, Recall # D-1913-2009;

16) FOSAMAX, ALENDRONATE SODIUM, 10MG TAB, Mfg MSD, NDC 00006-0936-58, Recall # D-1914-2009;

17) TIAZAC, DILTIAZEM ER, 360MG CAP, Mfg. FOR, NDC 00456-2616-30, Recall # D-1915-2009;

18) LEVOTHROID, LEVOTHYROXINE SOD 150MCG TAB, Mfg FOR, NDC 00456-1325-01, Recall # D-1916-2009;

19) LOTREL, AMLODIPINE/BENAZEPRL10/20MG CAP, Mfg. NVT, NDC 00078-0364-05, Recall # D-1917-2009;

20) LOTREL, AMLODIPINE/BENAZEPRL 2.5/10MG CAP, Mfg. NVT, NDC 00078-404-05, Recall # D-1918-2009;

21) PROPRANOLOL HCL, 20MG TAB, Mfg WAT, NDC 00591-5555-01, Recall # D-1919-2009;

22) SIMVASTATIN 40MG TAB, Mfg. RED, NDC 55111-0200-30, Recall # D-1920-2009;

23) NITROGLYCERIN, EXTENDED-RELEASE 9MG CAP, Mfg. QLT, NDC 00603-4784-20, Recall # D-1921-2009;

24) KETOPROFEN 75MG CAP, Mfg TEV, NDC 00093-3195-01, Recall # D-1922-2009;

25) CARDIZEM CD, DILTIAZEM HCL, 240MG CAP, Mfg. BIO, NDC 64455-0797-42, Recall # D-1923-2009;

26) FLORICAL CALCIUM/FLUORIDE 145/3.75MG CAP, Mfg MER, NDC 00394-0102-02, Recall # D-1924-2009;

27) SURMONTIL, TRIMIPRAMINE 50MG CAP, Mfg. DMD, NDC 51285-0539-02, Recall # D-1925-2009;

28) LOTENSIN HCT, BENAZEPRIL/HCTZ, 20/12.5MG TAB, Mfg NVT, NDC 00078-0453-05, Recall # D-1926-2009;

29) METHOCARBAMOL 750MG TABLET, Mfg. VIN, NDC 00603-4486-21, Recall # D-1927-2009;

30) DIOVAN HCT, VALSARTIN/HCTZ 80/12.5MG TAB, Mfg. NVT, NDC 00078-0314-34, Recall # D-1928-2009;

31) LEXAPRO, ESCITALOPRAM 10MG TAB, Mfg FOR, NDC 00456-2010-01, Recall # D-1929-2009;

32) GLIMEPRIDE 2MG TAB, Mfg PRS, NDC 66993-0163-02, Recall # D-1930-2009;

33) LABETALOL HCl, sub: TRANDATE 100MG TAB, Mfg WAT, NDC 00591-0605-01, Recall # D-1931-2009;

34) PROPAFENONE, sub: RYTHMOL 150MG TAB, Mfg ETH, NDC 58177-0331-04, Recall # D-1932-2009;

35) FLUOXETINE, sub: PROZAC 20MG CAP, Mfg. MAL, NDC 00406-0663-01, Recall # D-1933-2009;

36) MYSOLINE, PRIMIDONE 50MG TAB, Mfg ICN, NDC 66490-0690-10, Recall # D-1934-2009;

37) TRANDOLAPRIL, 2MG TAB, Mfg AUP, NDC 65862-0165-01, Recall # D-1935-2009;

38) NAPROXEN SOD, 550MG TAB, Mfg. TEV, NDC 00093-0537-05, Recall # D-1936-2009;

39) FOSINOPRIL / HCTZ, MONOPRIL/HCTZ 10/12.5MG TAB, Mfg R/P, NDC 63304-0403-01, Recall # D-1937-2009;

40) MEDROXYPROGESTERONE, 2.5MG TAB, Mfg BAR, NDC 00555-0872-02,  
D-1938-2009;

41) FOLAMIN FA/B12/B6, 2.5/2/25MG TAB, Mfg. MLT, NDC 68308-0780-90, Recall # D-1939-2009;

42) LEVOTHYROXINE TABLET 100MCG (0.1MG) Mfg. LAN, NDC 00527-1345-01, D-1940-2009;

43) LEVOTHYROXINE TABLET 75MCG (0.075MG) LAN, NDC 00527-1343-01, Recall # D-1941-2009;

44) NOVOLIN, 70/30 U-100, HUM NPH/REG INSULIN 70-30 U/ML VIAL 10ML, Mfg NPH NDC 00169-1837-11, Recall # D-1942-2009;

45) NOVOLOG, INSULIN ASPART INJ., 100U/ML VIAL 10 ML, Mtg. NPH, NDC 00169-7501-11, Recall # D-1943-2009;

46) ONDANSETRON, 4 mg/2 ml, Ondansetron Inj. (2 mg/ml), Recall # D-1944-2009;

47) AMITIZA LUBIPROSTONE 24 MCG GELCAP, Recall # D-1945-2009;

48) LANOXIN PED DIGOXIN QTY 1 ML 100MCG/ML AMP, Recall # D-1946-2009;

49) GAS FREE SIMETHICONE 125MG SOFTGEL, Recall # D-1947-2009;

50) GLYCERIN CHILD SUP SANI-SUPP Glyc. Suppos. PEDIATRIC SUP, Recall # D-1948-2009
CODE
1) Mfg. Lot 758218A, Exp. 05/14/09;
2) Mfg. Lot 46997, Exp. 11/14/09;
3) Mfg. Lot 856964A, Exp. 11/10/09;
4) Mfg. Lot 46412, Exp. 08/15/09;
5) Mfg. Lot 015307, Exp 02/27/09;
6) Mfg. Lot 7KE0127, Exp. 02/27/09;
7) Mfg. Lot 07072604, Exp. 02/27/09;
8) Mfg. Lot 56777AF21, Exp. 02/27/09;
9) Mfg. Lot 10032, Exp. 02/28/09;  
10) Mfg. Lot 7ABS, Exp. 02/28/09;
11) Mfg. Lot U1031, Exp. 02/28/09;
12) Mfg. Lot 54011X8, Exp. 02/28/09;
13) Mfg. Lot 8741360212, Exp 02/12/09;
14) Mfg. Lot 36514301, Exp 02/28/09;
15) Mfg. Lot 111699, Exp 02/28/09;
16) Mfg. Lot U1144, EXP 02/19/09;
17) Mfg. Lot P070805, Exp 02/19/09;
18) Mfg. Lot 100721, EXP 02/19/09;
19) Mfg. Lot F0405, EXP 02/19/09;
20) Mfg, Lot F0116, EXP 02/19/09;
21) Mfg. Lot L7J1300, EXP 02/19/09;
22) Mfg. Lot C73723, EXP 02/19/09;
23) Mfg. Lot M042R, EXP 12/01/08;
24) Mfg. Lot 28600, EXP 02/19/09;
25) Mfg. Lot 1101888, EXP 02/19/09;
26) Mfg. Lot 55007 EXP 02/19/09;
27) Mfg. Lot 7197001SA, EXP 02/20/09;
28) Mfg. Lot F0117A, EXP 02/20/09;
29) Mfg. Lot T145K07A, EXP 02/20/09;
30) Mfg. Lot F0206, EXP 02/21/09;
31) Mfg. Lot M0703L, EXP 02/21/09;
32) Mfg. Lot 1101822, Exp 02/21/09;
33) Mfg. Lot 60501G07, EXP 02/24/09;
34) Mfg. Lot 83470, Exp 02/24/09;
35) Mfg. Lot 0663L61339, Exp. 02/24/09;
36) Mfg. Lot B060002, Exp. 01/01/09;
37) Mfg. Lot TL 0207001, Exp 02/25/09;
38) Mfg. Lot 35300992A, Exp 02/25/09;
39) Mfg. Lot 1753929, Exp 02/01/09;
40) Mfg. Lot 305451, Exp 02/26/09;
41) Mfg. Lot 400015, Exp 02/26/09
42) Mfg. Lot 015607, Exp. 02/27/09;
43) Mfg. Lot 017407, Exp 02/27/09
44) Mtg. Lot V2FOO53, Exp. 06/01/10;
45) Mtg. Lot VZFO216, Exp. 11/30/10;
46) Mtg. Lot 1160074, Exp. 05/01/09;
47) Mtg. Lot 57436511 Exp 02/06/09;
48) Mfg. Lot A26517, Exp. 04/01/10;
49) Mtg. Lot S959, Exp. 07/01/10;
50) Mfg. Lot 210208004, Exp. 06/01/11
RECALLING FIRM/MANUFACTURER
Advantage Dose LLC, Shreveport LA, by telephone, electronic mail, and letter beginning November 26, 2008. Firm initiated recall is ongoing.
REASON
Not in conformance with cGMPs
VOLUME OF PRODUCT IN COMMERCE
Total 2,635663 unit doses
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1114-09
CODE
 Unit: 020GH28502
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Boise, ID, by telephone on February 2, 2009 and letter on February 3, 2009.
Manufacturer: American National Red Cross, Helena, MT. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of Hepatitis A, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
1) Source Plasma, Recall # B-1178-09;
2) Recovered Plasma, Recall # B-1179-09
CODE
1) Units: KZ009687, KP098310, KZ009543, KP097812, 06MTNA0146, 05MTNB3808; 
2) Units: KP098130, KP098008
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by fax on August 29, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
Austria, NC, CA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1346-09
CODE
Unit: W035209057160M  
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone and facsimile on March 19, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT 
Red Blood Cells, Recall # B-1392-09
CODE
Unit: W088609400506
RECALLING FIRM/MANUFACTURER
Providence Health System Southern California, Burbank, CA, by telephone on May 27, 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
CA
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-1413-09
CODE
Unit: 1689491
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, Hawaii, by facsimile on March 5, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced, Recall # B-1449-09;
2) Recovered Plasma, Recall # B-1450-09
CODE
1) and 2) Unit: 6396259
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by letter or electronic mail on January 23, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria, FL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1453-09
CODE
Unit: 6581057
RECALLING FIRM/MANUFACTURER
Carter BloodCare/WE & Lela I Stewart Blood Center, Inc., Tyler, TX, by letter dated December 19, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was taking the medication Requip, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT 
1) Red Blood Cells, Recall # B-1488-09;
2) Recovered Plasma, Recall # B-1489-09
CODE
1) and 2) Unit: W126908247145
RECALLING FIRM/MANUFACTURER
Southeastern Community Blood Center, Tallahassee, FL, by fax on April 8, 2009 and follow-up letter on April 17, 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
FL, Austria
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1490-09
CODE
Units: 2547893; 7523295
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter dated May 28, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced, Recall # B-1492-09;
2) Plasma Frozen, Recall # B-1493-09
CODE
1) and 2) Unit: W0420080004380
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Lafayette, LA, by telephone and letters beginning on July 16, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA, AZ
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced, Recall # B-1492-09;
2) Plasma Frozen, Recall # B-1493-09
CODE
1) and 2) Unit: W0420080004380
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Lafayette, LA, by telephone and letters beginning on July 16, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA, AZ
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1536-09;
CODE
Unit: 20T90727
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by fax and electronically on June 15, 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
UT, CA
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced, Recall # B-1539-09;
2) Red Blood Cells, Recall # B-1540-09
CODE
1) Unit: FG64171;
2) Unit: FG62278
RECALLING FIRM/MANUFACTURER
Piedmont Blood Center, Inc., Spartanburg, SC, by telephone and fax on April 17, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
SC
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1541-09;
2) Recovered Plasma, Recall # B-1542-09
CODE
1) and 2) Unit: W044108019097
RECALLING FIRM/MANUFACTURER
Siouxland Community Blood Bank, Sioux City, IA, by e-mail and letter dated March 3, 2009 and follow-up letter on March 10, 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
Austria, IA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1543-09
CODE
Unit: W117008155113
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone and letter on April 15, 2009. 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
CA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1544-09
CODE
Units: W047008569473A; W047008569473B; W047008562218A; W047008562218B; W047008545406 
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., Westbury, NY, by letter dated January 28, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
NJ, NY
___________________________________
PRODUCT 
1) Red Blood Cells, Recall # B-1545-09;
2) Fresh Frozen Plasma, Recall # B-1546-09
CODE
1) and 2) Unit: W089808202149
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Sterling, VA,  by letter dated January 9, 2009 and follow-up telephone call on January 23, 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
VA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________
PRODUCT 
DMS –Donor Management System Blood Establishment Computer System, Recall # B-1381-09
CODE
DMS versions 1.7.1, 1.8.0, 1.9.0, 1.9.1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Haemonetics Corp., Braintree, MA, by letter dated April 3, 2009.
Manufacturer: Haemonetics Software Solutions, Edmonton, Canada. Firm initiated recall is ongoing.
REASON
Software, with a defect or glitch, was distributed.
VOLUME OF PRODUCT IN COMMERCE
26 systems
DISTRIBUTION
CA, FL, LA, GA, OH, NC, and Canada
___________________________________
PRODUCT 
Donor Management System (DMS) Blood Management Computer System, Recall # B-1382-09
CODE
Software versions 1.7.1, 1.8.0, 1.8.1. 1.9.0, 1.9.1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Haemonetics Corp., Braintree, MA, by letter May 22, 2009.
Manufacturer: Haemonetics Software Solutions, Edmonton, Canada. Firm initiated recall is ongoing.
REASON
Software, with a defect or glitch, was distributed.
VOLUME OF PRODUCT IN COMMERCE
11 systems
DISTRIBUTION
CA, FL, GA, OH, NC, and Canada
___________________________________
PRODUCT 
1) Plasma Frozen within 24 hours (FP24), Recall # B-1411-09;
2) Red Blood Cells Leukocytes Reduced, Recall # B-1412-09
CODE
1) Unit: 3286701;
2) Units: 3286701, 3279809  
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by letter dated February 16, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking antibiotics at the time of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
Red Blood Cells Deglycerolized Leukocytes Reduced, Recall # B-1414-09
CODE
Unit: W035808065710
RECALLING FIRM/MANUFACTURER
BloodSource, Inc., Mather, CA, by telephone and facsimile on February 27, 2009. Firm initiated recall is complete.
REASON
Blood product, for which quality control testing for red cell recovery was not performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1415-09
CODE
Unit: 9357379 (Parts 1, 2, and 3
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on March 24, 2008 and by letter dated March 25, 2008. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Propionibacterium acnes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
Source Plasma, Recall # B-1429-09
CODE
Unit: AQ030439
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Asheville, NC, by facsimile on September 28, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
Haemonetics LN620 PCS2 Plasma Harness Set Model Number: LN620, Recall # B-1434-09
CODE
Lot Numbers: 081219511, 081219512, 081222510, 081222511, 081223510, 081223511, 081224510, 081224511, 081224512
RECALLING FIRM/MANUFACTURER
Haemonetics Corp., Braintree, MA, by letter dated April 10, 2009. Firm initiated recall is ongoing.
REASON
Plasma harness collection sets, with potential leaks at the blood filter, were distributed.
VOLUME OF PRODUCT IN COMMERCE
179,000 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
Red Blood Cells Washed, Recall # B-1487-09
CODE
Units: W117009183133; W117009181669
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on March 31, 2009 and follow up letter dated May 11, 2009. Firm initiated recall is complete.
REASON
Blood products, labeled with extended expiration dates, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
Recovered Plasma, For Manufacturing Use Only, Recall # B-1537-09
CODE
Unit: 20T90727
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by fax and electronically on June 15, 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
UT, CA
___________________________________
PRODUCT 
Source Plasma, Recall # B-1538-09
CODE
Unit: AQ030349
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Asheville, NC, by fax on September 20, 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
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1555-09
CODE
Unit: AQ030440
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Asheville, NC, by fax on October 2, 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
NC

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________
PRODUCT 
Bausch & Lomb, Boston Conditioning Solution, Original Formula, For Rigid Gas Permeable Contact Lenses, 1 fl. oz. (30 ml), Recall # Z-1735-2009
CODE
Lot Number: GA7060, Expires January 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bausch & Lomb, Inc., Rochester, NY, by letter dated June 26, 2009.
Manufacturer: Bausch & Lomb, Inc., Greenville, SC. Firm initiated recall is ongoing.
REASON
The product failed to meet one of the shelf life specifications at the end of the expiry period.
VOLUME OF PRODUCT IN COMMERCE
56,000 bottles
DISTRIBUTION
Nationwide
__________________________________
PRODUCT 
1) Medtronic INTREPID Spinal System SPACER, 32X23, 8 DEG, Size: 10MM, Part Number: REF 7961810; 12MM, REF 7961812; 14MM, REF 7961814; 16MM, REF 7961816; 18MM, REF 7961818; 20MM, REF 7961820; Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease, Recall # Z-1796-2009;

2) Medtronic INTREPID Spinal System SPACER, 32X23, 12 DEG, Size: 10MM, Part Number: REF 7961210; 12MM, REF 7961212; 14MM, REF 7961214; 16MM, REF 7961216; 18MM, REF 7961218; 20MM, REF 7961220; Rx only, STERILE R The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease, Recall # Z-1797-2009;

3) Medtronic INTREPID Spinal System SPACER M 37X27, 8 DEG, Size 10MM, Part Number: REF 7962810; 12MM, REF 7962812; 14MM, REF 7962814; 16MM, REF 7962816; 18MM, REF 7962818; 20MM, REF 7962820; USA, Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease, Recall # Z-1798-2009;

4) Medtronic INTREPID Spinal System SPACER M 37X27, 12 DEG, Size: 10MM, Part Number: REF 7962210; 12MM, REF 7962212; 14MM, REF 7962214; 16MM, REF 7962216; 18MM, REF 7962218; 20MM, REF 7962220; USA, Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease, Recall # Z-1799-2009;

5) Medtronic INTREPID Spinal System SPACER L 42X30, 8 DEG, Size: 10MM: Part Number: REF 7963810; 12MM, REF 7963812; 14MM, REF 7963814; 16MM, REF 7963816; 18MM, REF 7963818; 20MM, REF 7963820; USA, Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease, Recall # Z-1800-2009;

6) Medtronic INTREPID Spinal System SPACER L 42X30, 12 DEG, Size: 10MM, Part Number: REF 7963210; 12MM, REF 7963212, 14MM, REF 7963214; 16MM, REF 7963216; 18MM, REF 7963218; 20MM, REF 7963220; USA, Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease, Recall # Z-1801-200;

7) Medtronic INTREPID Spinal System Coverplate, size: Small, Part Number: REF 7961330; medium, REF 7962330; large, REF 7963330; STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease. Recall # Z-1802-2009;

8) Medtronic SOFAMOR DANEK INTREPID SPINAL SYSTEM, 5.5MM TAPERED SCREW, Length: 20MM, , Part Number: REF 7960020; 25MM, REF 7960025, 30MM, REF 7960030; and 35MM, REF 7960035; QTY: 1 EA, NON-STERILE, Rx only. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease, Recall # Z-1803-2009 
CODE
All lots
RECALLING FIRM/MANUFACTURER
Medtronic Sofamor Danek USA Inc, Memphis, TN, by telephone beginning February 6, 2009 and by letter dated April 2009.
Manufacturer: Medtronic Sofamor Danek Deggendorf GmbH, Deggendorf, Bavaria, Germany. Firm initiated recall is ongoing.
REASON
The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.
VOLUME OF PRODUCT IN COMMERCE
8,028 units
DISTRIBUTION
Nationwide, Australia, Germany, The Netherlands, and South Africa
___________________________________
PRODUCT 
BD 60ml Syringe Luer-Lok tip, Sterile, Product Number: 309653, Recall # Z-1811-2009
CODE
Lot Number: 819101A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letter dated July 7, 2009.
Manufacturer: Becton Dickinson & Company, Columbus, NB. Firm initiated recall is ongoing.
REASON
Insufficient Seal
VOLUME OF PRODUCT IN COMMERCE
133,600 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Respironics Esprit Ventilator System, Model Number V1000 with Optional External Battery; Product Number: 1001456, Recall # Z-1813-2009
CODE
Serial Numbers: VS2700460, VS2700540, VS2700542, VS2700557, VS2700564, VS2700581, VS2700584, VS2700585, VS2700134, VS2700140, VS2700547, VS2700573, VS2700127, VS2700632, VS2700633, VS2700634, VS2700676, VS2700690, VS2700693, VS2700647, VS2700641, VS2700678, VS2700679, VS2700517, VS2500580, VS2700596, VS2700599, VS2700606, VS2700910, VS2701416, VS2700536, VS2700550, VS2700551, VS2700553, VS2700561, VS2700122, VS2700123, VS2700124, VS2700125, VS2700201, VS2700399, VS2700409, VS2700410, VS2700411, VS2700414, VS2700417, VS2700662, VS2700923, VS2700927, VS2700432, VS2700438, VS2700440, VS2700441, VS2700442, VS2700331, VS2700332, VS2700336, VS2700359, VS2700390, VS2700556, VS2700563, VS2700459, VS2700318, VS2700319, VS2700320, VS2700321, VS2700119, VS2700209, VS2700610, VS2700646A, VS2700691, VS2700630, VS2700360, VS2700412, VS2700200, VS2700463, VS2700464, VS2700466, VS2700467, VS2700468, VS2700469, VS2700470, VS2700473, VS2700474, VS2700476, VS2700477, VS2700478, VS2700479, VS2700480, VS2700481, VS2700431, VS2700433, VS2700434, VS2700435, VS2700436, VS2700437, VS2700439, VS2700471, VS2700472, VS2700475, VS2700355, VS2700392, VS2700102, VS2700138, VS2700141, VS2700206, VS2700207, VS2700356, VS2700358, VS2700368, VS2700383, VS2700384, VS2700385, VS2700386, VS2700387, VS2700388, VS2700391, VS2700613, VS2700619, VS2700621, VS2700622, VS2700623, VS2700346, VS2700348, VS2700349, VS2700350, VS2700351, VS2700352, VS2700353, VS2700354, VS2700361, VS2700362, VS2700363, VS2700365, VS2700366, VS2700367, VS2700370, VS2700375, VS2700377, VS2700380, VS2700381, VS2700382, VS2700508, VS2700512, VS2700526, VS2700528, VS2700529, VS2700322, VS2700328, VS2700329, VS2700330, VS2700403, VS2700405, VS2700407, VS2700408, VS2700506, VS2700515, VS2700516, VS2700393, VS2700394, VS2700395, VS2700413, VS2700415, VS2700418, VS2700419, VS2700424, VS2700426, VS2700427, VS2700428, VS2700430, VS2700698, VS2700920, VS2701403, VS2701407, VS2700333, VS2700334, VS2700335, VS2700337, VS2700338, VS2700339, VS2700340, VS2700342, VS2700343, VS2700443, VS2700444, VS2700445, VS2700448, VS2700450, VS2700451, VS2700452, VS2700454, VS2700672, VS2700692, VS2700906, VS2700908, VS2700915, VS2701401, VS2701405, VS2701404, VS2700208, VS2700211, VS2700213, VS2700232, VS2700236, VS2700396, VS2700397, VS2700398, VS2700615, VS2700629, VS2700530, VS2700611, VS2700453, VS2700525, VS2700531, VS2700105, VS2700142, VS2700143, VS2700909, VS2700913, VS2700914, VS2700132, VS2700456, VS2700644, VS2700685, VS2700696, VS2700701, VS2700325, VS2700327, VS2700715, VS2700916, VS2700369, VS2700371, VS2700372, VS2700373, VS2700374, VS2700376, VS2700378, VS2700379, VS2700583, VS2700635, VS2700640, VS2700643, VS2700646, VS2700713, VS2700937, VS2701417, VS2700677, VS2700549, VS2700558, VS2700578, VS2700543, VS2700577, VS2700121, VS2700567, VS2700919, VS2700237, VS2700300, VS2700502, VS2700505, VS2700513, VS2700518, VS2700519, VS2700520, VS2700680, VS2700700, VS2700710, VS2700712, VS2700911, VS2700912, VS2700918, VS2700921, VS2700922, VS2700924, VS2700625, VS2700628, VS2700651, VS2700652, VS2700608, VS2700447, VS2700210, VS2700212, VS2700216,, VS2700217, VS2700218, VS2700219, VS2700220, VS2700221, VS2700222, VS2700223, VS2700224, VS2700225, VS2700227, VS2700228, VS2700229, VS2700230, VS2700120, VS2700130, VS2700131, VS2700133, VS2700111, VS2700113, VS2700115, VS2700202, VS2700203, VS2700234, VS2700235, VS2700301, VS2700302, VS2700303, VS2700304, VS2700305, VS2700306, VS2700307, VS2700308, VS2700309, VS2700310, VS2700311, VS2700312, VS2700313, VS2700314, VS2700315, VS2700316, VS2700317, VS2700657, VS2700658, VS2700659, VS2700667, VS2700668, VS2700687, VS2700901, VS2700902, VS2700903, VS2700904, VS2700907, VS2700527, VS2700539, VS2700541, VS2700554, VS2700555, VS2700589, VS2700590, VS2700597, VS2700600, VS2700601, VS2700602, VS2700603, VS2700604, VS2700598, VS2700609, VS2700612, VS2700586, VS2700587, VS2700588, VS2700595, VS2700716,, VS2700455, VS2700503, VS2700504, VS2700509, VS2700511, VS2700534, VS2700535, VS2700545, VS2700552, VS2700559, VS2700571, VS2700572, VS2700620, VS2700669, VS2700682, VS2700707, VS2700905, VS2700917, VS2700457, VS2700501, VS2700507, VS2700510, VS2700521, VS2700522, VS2700523, VS2700666, VS2700705, VS2700706, VS2700708, VS2700649, VS2700650, VS2700661, VS2700703, VS2700704, VS2700686, VS2700544, VS2700565, VS2700566, VS2700568, VS2700592, VS2700593, VS2700594, VS2700458, VS2700537, VS2700548, VS2700576, VS2700607, VS2700591, VS2700617, VS2700538, VS2700546, VS2700574, VS2700579, VS2700688, VS2700695, VS2700697, VS2700699, VS2700673, VS2700532, VS2700533, VS2700560, VS2700562, VS2700569, VS2700570, VS2700582, VS2700616, VS2700618, VS2700935, VS2700943, VS2700925, VS2700926, VS2700928, VS2700929, VS2700930, VS2700931, VS2700932, VS2700933, VS2700934, VS2700936, VS2700446, VS2700449, VS2700461, VS2700462, VS2700465, VS2701402, VS2701406, VS2700341, VS2700357, VS2700345, VS2700347, VS2700344, VS2700655, VS2700656, VS2700660, VS2700663, VS2700664, VS2700665, VS2700670, VS2700674, VS2700675,, VS2700683, VS2701653, VS2701655, VS2700204, VS2700205, VS2700214, VS2700215, VS2700684, VS2700694, VS2700118, VS2700714, VS2700231, VS2700233, VS2700401, VS2700402, VS2700404, VS2700406, VS2700420, VS2700421, VS2700422, VS2700423, VS2700702, VS2700938, VS2700109, VS2700126, VS2700129, VS2700135, VS2700136, VS2700137, VS2700139, VS2700654, VS2700671, VS2700719, VS2700108, VS2700389, VS2700614, VS2700626, VS2700627, VS2700128, VS2700689, VS2700717, VS2700718, VS2700709, VS2700711, VS2700939, VS2700940, VS2700941, VS2700942, VS2700636, VS2700637, VS2700638, VS2700639 and VS2700631
RECALLING FIRM/MANUFACTURER
Respironics California, Inc, Carlsbad, CA, by letter dated April 22, 2009. Firm initiated recall is ongoing.
REASON
The recall was initiated because through routine product monitoring Respironics discovered that under certain conditions, when operating on AC line power, a portion of the current from the External Battery charger is erroneously diverted to the ventilator. When this occurs, the External Battery charger may not transition correctly. Prolonged operation in this condition results in overcharging and accelerated aging of the battery cells. Using batteries beyond their useful life may lead to a ventilator restart and Vent Inop condition. Should a Vent Inop condition occur the ventilator will alarm both audibly and visually, and will cease to operate creating the potential for patient injury.
VOLUME OF PRODUCT IN COMMERCE
508 units
DISTRIBUTION
Nationwide and Hong Kong, India, Mexico, South Africa and Vietnam
___________________________________
PRODUCT 
1) Hospira Phoenix Infusion System with MedNet Software, Symbiq One-Channel Infusion System, Software versions v2.1 & v3.0, Recall # Z-1815-2009;

2) Hospira Phoenix Infusion System with MedNet Software, Symbiq Two-Channel Infusion System, Software versions v2.1 & v3.0, Recall # Z-1816-2009
CODE
1) List number 16026-04-83/84 and 87/88, software versions 2.1 and 3.0 only;
2) List number 16027-04-83/84 and 87/88, software versions 2.1 and 3.0 only
RECALLING FIRM/MANUFACTURER
Hospira, Inc., Morgan Hill, CA, by letter dated March 31, 2009. Firm initiated recall is ongoing.
REASON
Potential delay/under infusion of critical therapy-- Devices experience increased frequency of alarms that result in temporary pump stoppage.
VOLUME OF PRODUCT IN COMMERCE
12,222 Units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Edwards Lifesciences "VAMP Jr" (Venous Arterial blood Management Protection system), Recall # Z-1934-2009
CODE
Lot numbers: Product manufactured between 8/01/06 and 2/29/08; Product Codes: C7217C3A, C7217C6A, PXVJ0441, PXVJ0705, PXVJ0711, PXVJ0819, PXVJ084, PXVJ0926, PXVJ0993, PXVJ356, T005071A, T100802A, T100803A, T391R00A, T430168A, T430169A, T432902A, T440Z01A, T443952B, T450552C, T450553A, T463403A, T470228C, T470411B, VMP306, VMP306PX, VMP406, VMP406PX, VMP426, VMP426PX, VMP448, VMP448PX
RECALLING FIRM/MANUFACTURER
Edwards Lifesciences AG, Haina, San Cristobal, Dominican Republic, by letter dated March 10, 2008. Firm initiated recall is complete.
REASON
Edwards Lifescience initiated a recall of on Edwards "VAMP Jr" Pressure Monitoring Products manufactured between 8/01/06 and 2/29/08 due to the potential for the cap on the reservoir of the "VAMP Jr" to become disconnected.
VOLUME OF PRODUCT IN COMMERCE
61,199 units
DISTRIBUTION
Nationwide and the countries of Australia, Austria, Belgium, Brazil, Canada, Canaric Island (Spain), China, Columbia, Czech Republic, Denmark, France, Germany, Hungary, Italy, Japan, Kuwait, Netherlands, New Zealand, Norway, Puerto Rico, Spain, Sweden, Turkey, and United Kingdom
___________________________________
PRODUCT 
1) Stryker Reflex Hybrid Level Anterior Cervical Plate; Non Sterile; Catalog Number/Description: 48650112, Reflex Hybrid one-level plate, size 12mm; 48650114m size 14 mm; 48650116, 16 mm; 48650118, size 18mm; 48650120, size 20 mm; 48650122, size 22 mm. 48650224, Reflex Hybrid Two-Level Plate, size 24 mm; 48650226, size 26 mm; 48650228, size 28 mm; 48650230, size 30 mm; 48650232, size 32 mm; 48650234, size 34 mm; 48650237, size 37 mm; 48650240, size 40 mm; 48650243, size 43 mm; 48650246, size 46 mm. 48650339, Reflex Hybrid Three-Level Plate, Size 39 mm; 48650342, size 42mm; 48650345, suze 45 mm; 48650348, size 48 mm; 48650351, size 51 mm; 48650354, size 54 mm; 48650357, size 57 mm; 48650360, size 60 mm; 48650363, size 63 mm; 48650366, size 66 mm; 48650369, size 69 mm. 48650460, Reflex Hybrid four-Level Plate, size 60 mm; 48650464, size 64 mm; 48650468, size 68 mm; 48650472, size 72 mm; 48650476, size 76 mm; 48650489, size 80 mm; 48650484, size 84 mm, Recall # Z-1958-2009;

2) Stryker Reflex Hybrid variable self-drilling screw. Non Sterile. All Product with the following Catalog Number/ Description: 48664010, Variable Angle Bone Screw Self Drilling, Diameter 4.0 x 10 mm; 48664012, diameter 4.0 x 12 mm; 48604014, diameter 4.0 x 14 mm; 48664016, diameter 4.0 x 16 mm; 48664018, diameter 4.0 x 18 mm, Z-1959-2009;

3) Stryker Reflex Hybrid Variable Self-Tapping Screw. Non Sterile. Catalog Number/Description: 48684012, Variable Angle Bone Screw, diameter 4.0 x 10 mm; 48684012, diameter 4.0 x 12 mm; 48684014, diameter 4.0 x 14 mm; 48684018, diameter 4.0 x 18 mm; 48684020, diameter 4.0 x 20 mm; 48684512, diameter 4.5 x 12 mm; 48684516, diameter 4.5 x 14 mm; 48684516, diameter 4.5 x 16 mm; 48684518, diameter 4.5 x 18 mm; 48684520, diameter 4.5 x 20 mm, Recall # Z-1960-2009
CODE
All Product with the above Catalog Numbers
RECALLING FIRM/MANUFACTURER
Stryker Spine, Allendale, NJ, by letter dated June 14, 2006.
Manufacturer: Stryker Spine, Cestas, Aquitane, France. Firm initiated recall is complete.
REASON
Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All in One Guide, was not used.
VOLUME OF PRODUCT IN COMMERCE
38,987 plates, 109,572 screws
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS III

___________________________________
PRODUCT 
Farnam D-Worm 60 (pyrantel pamoate) Liquid for Puppies and Dogs, containing 2.27 mg/ml of pyrantel pamoate base as pyrantel pamoate per ml, 2-fl. oz. bottles, RX, ANDA #200-248, NDC 017135-703-12, Recall # V-257-2009
CODE
Lot: 8110816, Exp. 11-2010
RECALLING FIRM/MANUFACTURER
TEVA Animal Health, Inc., Saint Joseph, MO, by letter dated May 20, 2009. Firm initiated recall is ongoing.
REASON
Stability failure for potency
VOLUME OF PRODUCT IN COMMERCE
10,423/2-fl. oz. bottles
DISTRIBUTION
AZ
___________________________________
PRODUCT 
Bulk ground corn; distributed by Saginaw Flakes, Saginaw, TX, Recall # V-258-2009
CODE
Bulk ground corn shipped between 05/13/-14/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fargam Land & Grain, Saginaw, TX, by telephone on May 21, 2009.
Manufacturer: Mars Petcare US, Clinton, OK. Firm initiated recall is ongoing.
REASON
Bulk ground corn used as feed for ruminant animals may have been contaminated with prohibited material.
VOLUME OF PRODUCT IN COMMERCE
429,128 lbs.
DISTRIBUTION
TX, LA

END OF ENFORCEMENT REPORT FOR SEPTEMBER 2, 2009

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