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U.S. Department of Health and Human Services

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Enforcement Report for July 15, 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.

July 15, 2009
09-28

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

___________________________________
PRODUCT 
1) Milk Chocolate Peanut Butter Cups sold in cellophane bags, in clear plastic tubs, or in bulk. The peanut butter cups are 1.25 inches in diameter and inch thick. The product was distributed under the following labels and sizes: (a) Landies Premium Milk Chocolate Peanut Butter Cups, 11 oz. bags, UPC 013065502167; (b) Wegmans Swiss Recipe Ultimate Peanut Butter Cups, 8 oz. hard plastic tubs, UPC 77890 12946, (c) Wegmans Swiss Recipe Ultimate Peanut Butter Cups also available at Wegmans in bulk food bins and in random weight packages, Bin # 79966. Recall # F468-9

2) Wegmans Swiss Recipe Chocolate Holiday Platters containing Ultimate Peanut Butter Cups. The Holiday Platters contain 4-5 different snack items, and were sold under the following sizes and codes: (a) Wegmans Swiss Recipe Medium Chocolate Holiday Platters, 23 oz., UPC 77890 15526; (b) Wegmans Swiss Recipe Large Chocolate Holiday Platter, 51 oz., UPC 77890 15529; (c) Wegmans Swiss Recipe Large Chocolate Holiday Platter with Sponge Candy, 49 oz., UPC 77890 15530. Recall # F-469-9;

3) Landies Candies brand certified organic Pure Milk Chocolate Peanut Clusters, Net Wt. 4 oz. (113G) - UPC 0 13065 50175 7, Net Wt. 8 oz. (227G) - UPC 0 13065 50176 4, and in bulk form. Recall # F-470-9;

4) Landies Candies brand certified organic Pure Dark Chocolate Peanut Clusters, Net Wt. 4 oz. (113G) - UPC # 0 13065 50177 1, Net wt. 8 oz. (227G) - UPC # 0 13065 50178 8, and in bulk form. Recall # F-471-9
CODE
1) (a) Lot # 345; (b) Lot # 273; (c) Bin # 79966, sold between 10-31-08 and 1-21-09;

2) (a) Sold between 10-31-08 and 1-21-09; (b) Sold between 10-31-08 and 1-21-09; (c) Sold between 10-31-08 and 1-21-09;

3), 4) Sold from 1-01-07 thru 1-30-09
RECALLING FIRM/MANUFACTURER
Landies Candies, Inc, Buffalo, NY, by press release on January 21, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Approx. 3,500 lbs
DISTRIBUTION
NY, PA, NJ, MD and VA
___________________________________
PRODUCT 
Peanut Butter Pie, a frozen food service pie, Net Wt. 4 x 1.75 LBS., scored 6 slices, 1 pie in an aluminum plate per box, 4 pies per master case; Pie Piper item 61928, GFS product #520421. Recall # F-472-9
CODE
Lot 8289 and 8169
RECALLING FIRM/MANUFACTURER
Distinctive Foods Llc Dba Pie Piper Products Ltd, Bensenville, IL, by telephone and e-mail on January 22, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
120 cases
DISTRIBUTION
IL, IN, MI, and WI
___________________________________
PRODUCT 
East Side Entrees Peanut Butter & Jelly Meal BREAKS meal kit; Product Number 61402, UPC 006 93392 61402 5. Pack size: 30 meal kits per shipping case. Each meal kit consists of multiple fully packaged shelf-stable food components including a 2.2 oz. packet of peanut butter (the affected component), a jelly packet, two packages of graham crackers, an apple sauce cup, and a fruit juice box. Product is primarily distributed to schools as a foodservice item. It is not a retail item and it is not sold in retail stores. Recall # F-473-9
CODE
Use By June 24 09, (9175TESxxx)
RECALLING FIRM/MANUFACTURER
Recalling Firm: East Side Entrees, Woodbury NY, by telephone on January 20-21, 2009 and press release on January 31, 2009.
Manufacturer: Boca Grande Foods / Modern Packaging, Duluth, GA. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
480 cases (14,400 individual meal kits)
DISTRIBUTION
CA, AR, FL, MI, HI, and PA
___________________________________
PRODUCT 
LesserEvil brand Peanut Butter & Choco Kettle Corn, ALL NATURAL ---3.65 oz. bag in a box --- UPC of the product distributed in the US and Japan is 180999000356, UPC for the Canadian product is 180999000516. Recall # F-474-9
CODE
All lot codes; Best by dates 11/23/08 through 10/10/09 (printed on inside bag)
RECALLING FIRM/MANUFACTURER
LesserEvil Brand Snack Company, Tuckahoe, NY, by press release, e-mail, fax, telephone and letters on January 30, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
39,636 units
DISTRIBUTION
Nationwide, Canada and Japan
___________________________________
PRODUCT 
1) Peanut Butter Cookie Shop Cookies sold by the pound only in Wegmans stores with a full-service Cookie Shop, UPC 2-08165-00000 (Commodity Code 062010), and frozen Peanut Butter Cookie Puck by the case (Commodity Case 180916) to be baked at Wegmans stores with full-service Cookie Shop. Recall # F-475-9;

2) In store Baked Peanut Covered Donuts sold individually at Wegmans in-store bakeries (Commodity Code 28444). Recall # F-476-9;

3) Chocolate Peanut Butter Tarts sold whole - large, UPC 2-08491-00000 (Commodity Code 280054) and by the slice, UPC 2-08254-00000 (Commodity Code 293256) in Wegmans stores with a full-service Patisserie, and Unfinished Frozen Chocolate Peanut Butter Tarts (Commodity Code 280053). Recall # F-477-9;

4) In store Granulated Peanuts used to cover peanut donuts, 30 lbs. (Commodity Code 237837). Recall # F-478-9
CODE
All lot codes produced in the Central Bakeshop from April 1, 2009 until Jan 29, 2009
RECALLING FIRM/MANUFACTURER
Wegmans Food Markets, Rochester, NY, by press release and e-mail on January 29, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Cookies – 72,600; Donuts – 400,000; Tarts – 3,614; Granulated Peanuts – quantity unknown
DISTRIBUTION
NY, PA, NJ, VA, and MD

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II

___________________________________
PRODUCT
Chai Concentrate in half gallon plastic bottle Front Label reads "TIPU'S TIGER chai CHAI CONCENTRATE MADE IN MONTANA half gallon (1.89L)" Rear Label reads "CHAI CONCENTRATE Net weight 64 oz. makes approximately 12 cups. Ink jet sprayed lid reads "REFRIGERATE AFTER OPENING". Recall # Recall # F-466-9
CODE
Date codes 09/23/09 through and including 05/21/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mission Mountain Food Enterprise Center, Ronan MT, by telephone and letter on June 12, 2008 and by press release on June 17, 2008. Firm initiated recall is ongoing.
REASON
Product is inadequately processed to prevent the outgrowth and toxin production of pathogens of public health concern, particularly Clostridium botulinum.
VOLUME OF PRODUCT IN COMMERCE
6,663 one half gallon containers 
DISTRIBUTION
MT, AZ
___________________________________
PRODUCT
Sliced jalapeno peppers labeled as la torre Nacho Sliced Jalapeno Net Wt 425 g Drained  Wt 225 g UPC 7501067471770; Product of Mexico. Recall # 467-9
CODE
Lot Numbers: AU4D6; AU4E6; AU515; AU516; AU520; AU526; AU5H6; AU5L6; AU5M6; AU8W6; AU955; AU9V5; AU9W5; AU9X5; AU9Y5; AU9Z5 (In some cases these lots may have a letter A or B proceeding the lot #, for example AU4D6A OR AU4D6B). Some cans may bear no lot number. The lot code is located on the bottom of the can.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Peppers Unlimited Inc, Fontana, CA, by letters dated August 14, 2008 and by press release on August 15, 2008.
Manufacturer: Conservas La Torre S.A. de C.V., Cuatitlan Izcalli, Mexico. Firm initiated recall is ongoing.
REASON
The recall was initiated because of possible product contamination caused by a chemical reaction between the product and the can potentially resulting in a swollen and/or ruptured container and significant off flavor.
VOLUME OF PRODUCT IN COMMERCE
751 cases/24 cans per case
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT 
1) Methyldopa/ HCTZ, 250/25 MG TAB, Mfg. MYL, Rx Only. Recall # D-1276-2009; 

2) Paxil CR, Paroxetine, 37.5 MG TAB, Mfg. GSK, Rx Only. Recall # D-1277-2009;

3) Levothroid, Levothyroxine Na, 200MCG TAB, Mfg. FOR, Rx Only. Recall # D-1278-2009;
 
4) Disopyramide PHOS, 100MG CAP, Mfg. WAT, Rx Only. Recall # D-1279-2009;

5) Depakote, Divalproex Sodium, 125MG TAB, Mfg. ABB, Rx Only. Recall # D-1280-2009;

6) Loxapine SUC, 25MG CAP, Mfg. WAT, Rx Only. Recall # D-1281-2009;

7) Gabapentin, 400MG CAP, Mfg. A-C, Rx Only. Recall # D-1282-2009;

8) Levothyroxine Injection, 200MCG Vial, Mfg. BVL, Rx Only. Recall # D-1283-2009;

9) Vitamin B-6, Pyridoxine, 50MG TAB, Mfg. V-1, OTC. Recall # D-1284-2009;

10) Albuterol Sulf, 2MG TAB, Mfg. URL, Rx Only. Recall D-1285-2009;

11) HydrOXYzine Pamoate, sub: VISTARIL, 50MG CAP, Mfg. SDZ, Rx Only. Recall # D-1286-2009;

12) Zyrtec-D 12 Hour, P-EPHED/CETIRIZINE, 120/5MG TAB, Mfg. PFZ, NDC 00069-1630-66, OTC. Recall # D-1287-2009;

13) Trifluoperazine, 1MG TAB, Mfg. MYL, Rx Only. Recall # D-1288-2009;

14) Risperdal, Risperidone, 0.25MG TAB, Mfg. JPP, Rx Only. Recall # D-1289-2009;

15) Baclofen, 20MG TAB, Mfg. QLT, NDC 00603-2407-21, Rx Only. Recall # D-1290-2009;

16) Rifampin, 300MG CAP, Mfg. SDZ, Rx Only. Recall # D-1291-2009;

17) Amlodipine, Amlodipine Besylate, 5MG TAB, Mfg. MYL, Rx Only. Recall # D-1292-2009;
 
18) Baclofen, 10MG TAB, Mfg. QLT, NDC 00603-2406-21, Rx Only. Recall # D-1293-2009;

19) Excedrin Tension, APAP/ Caffeine, 500/65MG GELTAB, Mfg. NVT, OTC. Recall # D-1294-2009;

20) Maalox M/S Lemon, Ca CARB/Simethicone, 1000/60MG CHEW TAB, Mfg. NVT, NDC 00067-0371-65, OTC. Recall # D-1295-2009;

21) Aleve, Naproxen Sodium, 220MG TAB, Mfg. BAY, NDC 32586-6105-05, OTC. Recall # D-1296-2009;

22) Aspirin Suppositories, 300MG (5 GRAINS), Mfg. PAD, OTC. Recall # D-1297-2009;

23) Aplisol SOL, 1CC VL, Tuberculin PPD, Mfg. PPI, Rx Only. Recall # D-1298-2009;

24) Famotidine, sub: PEPCID AC, 10MG TAB, Mfg. GDL, NDC 00182-2662-19, OTC. Recall # D-1299-2009;

25) Promethazine, 12.5MG Suppositories, Mfg. PAD, Rx Only. Recall # D-1300-2009;

26) Preparation H, Phenylephrine, 0.25% Suppository, Mfg. W-R, OTC. Recall # D-1301-2009;

27) URO BLUE, TAB, Mfg. RAM, NDC 12830-0301-01, Rx Only. Recall # D-1302-2009;

28) Konsyl, Calcium Polycarb, 625MG CAP, Mfg. KON, NDC 00224-0500-90, OTC. Recall # D-1303-2009;

29) DIPHENhydramine SF AF, sub: Benadryl, 12.5MG/5ML Liquid 5ML, Mfg. IVX, NDC 00182-6168-40, OTC. Recall # D-1304-2009;

30) HydrOXYzine HCl, 25MG Tablet, Mfg. WAT, NDC 00591-5523-01, Rx Only. Recall # D-1305-2009;

31) Paroxetine HCl, 20MG TAB, Mfg. API, NDC 62037-0846-30, Rx Only. Recall #  D-1306-2009;

32) Cerovite Senior, Multivitamin W-MIN, TAB, Mfg. RUG, NDC 00536-3445-08, OTC. Recall # D-1307-2009;

33) URO-MAG, Magnesium Oxide, 140MG CAP, Mfg. BLA, NDC 00165-0054-01, OTC. Recall # D-1308-2009;

34) Citalopram, 10MG TAB, Mfg. RED, NDC 55111-0342-01, Rx Only. Recall # D-1309-2009;

35) Benicar, Olmesartan Medoxomil, 20MG Tablet, Mfg. DSI, NDC 65597-0103-90, Rx Only. Recall # D-1310-2009;
 
36) Methimazole, sub: Tapazole, 10MG TAB, Mfg. URL, NDC 00677-1946-01, Rx Only. Recall # D-1311-2009;

37) Lisinopril/HCTZ, 20/12.5 TAB, Mfg. IVX, NDC 00172-5034-60, Rx Only. Recall # D-1312-2009;

38) Isosorbide DIN, Isosorbide Dinitrate: 2.5MG SL TAB, Mfg. QLT, NDC 00603-4122-21, Rx Only. Recall # D-1313-2009;

39) Zyvox, Linezolid, 600MG TAB, Mfg. PFZ, NDC 00009-5135-02, Rx Only. Recall # D-1314-2009;

40) Diphenhydramine, 12.5MG/5ML and Alcohol 14%/5ml, 12.5MG/5ML 5ML 5ML, Mfg. 5ml, Rx Only. Recall # D-1315-2009;

41) Misoprostol, 100MCG TAB, Mfg. GRN, NDC 59762-5007-01, Rx Only. Recall # D-1316-2009; 

42) Tandem DHA, CAP, Mfg. USP, NDC 52747-0904-60, Rx Only. Recall # D-1317-2009;

43) Diovan, Valsartan, 80MG TAB, Mfg. NVT, NDC 00078-0358-34, Rx Only. Recall # D-1318-2009; 

44) Ranitidine HCl, sub: Zantac, 300MG TAB, Mfg. SNZ, NDC 00781-1884-25, Rx Only. Recall # D-1319-2009;

45) Estradiol Trans, 0.05MG/24H PAT, Mfg. MYL, Rx Only. Recall # D-1320-2009;

46) Avandaryl, Rosiglitazon/Glimep, 4MG/2MG TAB, Mfg. SKB, NDC 00007-3152-13, Rx Only. Recall # D-1321-2009;

47) Tandem CAP, FE Fumarate/FE PS CMPLX, Mfg. USP, Rx Only. Recall # D-1322-2009;

48) Travatan OPTH SOL, Travoprost, 0.004% DROP 2.5ML, Mfg. ALC, Rx Only. Recall # D-1323-2009;

49) Slow FE, Fe S04, 47.5MG, Mfg. NVT, OTC. Recall # D-1324-2009;

50) GAS-X E/S, Simethicone, 125MG SOFTGEL, Mfg. NVT, OTC. Recall # D-1325-2009;

51) Aspirin EC, 81MG, Aspirin EC Tablet, Mfg. IVX, OTC. Recall # D-1326-2009;

52) Stay Awake, Caffeine, 200MG Tablet, Mfg. GDD, OTC. Recall # D-1327-2009;

53) Acetaminophen SUP, 325MG, Acetaminophen Suppos., Mfg. G&W, OTC. Recall # D-1328-2009

54) Depakote DR, 125MG Divalproex Tablet, Mfg. ABB, Rx Only. Recall # D-1329-2009;

55) Eye Wash IRR SOL, 4 OZ, OML, Mfg. GDL, OTC. Recall # D-1330-2009;

56) Dornase ALFA Inhal. Sol., Pulmozyme 2500 U./AMP, Mfg. GNT, Rx Only. Recall # D-1331-2009; 

57) LACT-AID FAST ACT, Lactase, Mfg. MCN, OTC. Recall # D-1332-2009
CODE
1) Mfg. Lot 1S1604, Exp. 11/26/08;
2) Mfg. Lot 3087P08, Exp. 11/29/08;
3) Mfg. Lot 100723, Exp. 12/04/08;
4) Mfg. Lot L7B0252, Exp. 11/26/08;
5) Mfg. Lot 53873AA21, Exp. 12/04/08;
6) Mfg. Lot 37101E07, Exp. 11/26/08;
7) Mfg. Lot HL7449, Exp. 12/03/08;
8) Mfg. Lot 1139997, Exp. 08/01/09;
9) Mfg. Lot 300807, Exp. 12/04/08;
10) Mfg. Lot 59821, Exp. 11/27/08;
11) Mfg. Lot ML071390, Exp. 12/03/08;
12) Mfg, Lot 03297L, Exp. 12/05/08;
13) Mfg. Lot 3000661, Exp. 11/25/08;
14) Mfg. Lot 7LG490, Exp. 12/04/08;
15) Mfg. Lot T074G07A, Exp. 12/05/08;
16) Mfg. Lot ML071114, Exp. 11/27/08;
17) Mfg. Lot 3001045, Exp. 12/04/08;
18) Mfg. Lot T072G07C, Exp. 12/05/08;
19) Mfg. Lot 6J4508A, Exp. 12/03/08;
20) Mfg. Lot 10038164, Exp. 12/10/08;
21) Mfg. Lot 251157J, Exp. 12/18/08;
22) Mfg. Lot 7370915, Exp. 08/01/09;
23) Mfg. Lot 46376, Exp. 12/03/08;
24) Mfg. Lot BEAD4B, Exp. 02/01/09;
25) Mfg. Lot 7129497, Exp. 03/01/09;
26) Mfg. Lot C03612A, Exp. 05/01/09;
27) Mfg. Lot 071283, Exp. 12/17108;
28) Mfg. Lot E72602, Exp. 12/06/08;
29) Mfg. Lot 7K04, Exp. 12/10/08;
30) Mfg. Lot L7E0761, Exp. 12/12/08;
31) Mfg. Lot 20029, Exp. 12/18/08;
32) Mfg. Lot 13817060, Exp. 12/06/08;
33) Mfg. Lot 07050701, Exp. 12/13/08;
34) Mfg. Lot C71353, Exp. 12/19/08;
35) Mfg. Lot B0159, Exp. 12/06/08;
36) Mfg. Lot 0957, Exp. 12/13/08;
37) Mfg. Lot 162383A, Exp. 12/20/08;
38) Mfg. Lot 59623D, Exp. 12/09/08;
39) Mfg. Lot C070910, Exp. 12/10/08;
40) Mfg. Lot 7G61, Exp. 07/01/09;
41) Mfg. Lot C061262, Exp. 12/01/08
42) Mfg. Lot 07091201, Exp. 12/17/08;
43) Mfg. Lot F0308, Exp. 12/25/08;
44) Mfg. Lot 169358, Exp. 12/10/08;
45) Mfg. Lot 650069, Exp. 05/01/09;
46) Mfg. Lot 7ZP8339, Exp. 12/17/08;
47) Mfg. Lot 07072601, Exp. 08/01/09;
48) Mfg. Lot 137171F, Exp. 01/01/09;
49) Mfg. Lot 10037496, Exp. 03/01/10;
50) Mfg. Lot 99492, Exp. 02/01/10;
51) Mfg. Lot AD32TA, Exp. 01/01/09;
52) Mfg. Lot 7FE0738, Exp. 11/01/10;
53) Mfg. Lot 016407004, Exp. 04/01/11;
54) Mfg. Lot 53917AA21, Exp. 06/01/09;
55) Mfg. Lot GC7035, Exp. 03/01/10;
56) Mfg. Lot N57291, Exp. 03/01/09;
57) Mfg. Lot MN07076, Exp. 08/01/09
RECALLING FIRM/MANUFACTURER
Advantage Dose LLC, Shreveport, LA, by telephone, electronic mail, and letter beginning November 26, 2008. Firm initiated recall is ongoing.
REASON
Non-conformance with current Good Manufacturing Practices.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
AR, GA, IL, LA, MS, MO, OK, TX
___________________________________
PRODUCT 
1) Klonopin Wafers (clonazepam orally disintegrating tablets) 0.25 mg, 60 Tablets (10 x 6), Rx only, NDC 0004-0280-07 Made in Switzerland. Recall # D-1495-2009;

2) Klonopin Wafers (clonazepam orally disintegrating tablets) 0.5 mg, 60 Tablets (10 x 6), Rx only, NDC 0004-02810-22, Made in Switzerland. Recall # D-1496-2009

3) Klonopin Wafers (clonazepam orally disintegrating tablets) 1 mg, 60 Tablets (10 x 6), Rx only, NDC 0004-0282-22, Made in Switzerland. Recall # D-1497-2009;

4) Klonopin Wafers (clonazepam orally disintegrating tablets), 0.125 mg, 60 Tablets (10 x 6), Rx only, NDC 0004-0279-22, Made in Switzerland. Recall # D-1498-2009
CODE
1) Lot numbers: U2039-50, Exp. 9/2009; U2040-50, Exp 9/2009; U2041, Exp. 9/2009; U2041-01, Exp 9/2009; U2042, Exp 9/2011;
2) Lot U3039, Exp. 3/2011;
3) Lot U4017, Exp. 3/2011;   
4) Lot U1011, Exp. 2/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hoffmann La Roche Inc, Nutley, NJ, by letters on June 4, 2009.
Manufacturer: Cardinal Health, Swindon, United Kingdom. Firm initiated recall is ongoing.
REASON
Subpotent
VOLUME OF PRODUCT IN COMMERCE
36,982
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT 
Meijer brand Children’s Ibuprofen oral suspension, Berry Flavor, 100 mg/5 ml., 4 fl. oz; NDC 41250-685-26. Recall # D-1657-2009
CODE
Lots 8GK0243, 8KK0450, 8LK0475, 8LV0863, 9BK0458, 9CK0033 and 9CK0579
RECALLING FIRM/MANUFACTURER
L. Perrigo Co, Allegan, MI, by letter on April 27, 2009. Firm initiated recall is ongoing.
REASON
Labeling illegible; the allergy alert warnings on the label are missing letters. Warning should read: Symptoms may include hives, facial swelling, asthma/wheezing, shock, skin reddening, rash and blisters.
VOLUME OF PRODUCT IN COMMERCE
9,024 bottles
DISTRIBUTION
IL, IN KY, MI, OH

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1220-09
CODE
Unit: 0735678
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc, Jackson, MS, by fax on August 5, 2008. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
___________________________________
PRODUCT 
1) Fresh Frozen Plasma. Recall # B-1243-09;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1244-09 
CODE
1) and 2) Unit: 1718112
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood & Tissue Center, Austin, TX, by facsimile on December 14, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for testing positive for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1245-09   
CODE
Unit: 208451897
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc, Lafayette, LA, by telephone on November 20, 2006. 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
LA
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1247-09
CODE
Units: 203182669 (2 units)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc, Lafayette, LA, by letter dated November 15, 2006. Firm initiated recall is complete.
REASON
Blood products, which did not meet the minimum requirement for Red Blood Cell volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA
___________________________________
PRODUCT 
Cornea. Recall # B-1248-09
CODE
Units: LPT20060624R1, LPT20060624L1
RECALLING FIRM/MANUFACTURER
LifePoint, Inc, Charleston, SC, by telephone on March 19, 2007, by e-mail on March 24, 2007, and by letter dated April 20, 2007. Firm initiated recall is complete.
REASON
Human tissue for transplantation, collected from a donor whose blood sample for testing was hemodiluted, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 corneas
DISTRIBUTION
SC, Saudi Arabia
___________________________________
PRODUCT 
Red Blood Cells. Recall # B-1256-09
CODE
Unit: W089808462640
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Sterling, VA, by telephone on November 12, 2008 and by follow-up letter dated November 20, 2008. Firm initiated recall is complete.
REASON
Blood product, labeled “leukoreduced”, but which had not undergone leukoreduction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT 
Red Blood Cells. Recall # B-1257-09
CODE
Unit: W089808462681 (Part A and B)
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Sterling, VA, by telephone on November 12, 2008 and by follow-up letter dated November 20, 2008. Firm initiated recall is complete.
REASON
Blood products, labeled “leukoreduced”, but which had not undergone leukoreduction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MD, VA
___________________________________
PRODUCT 
Red Blood Cells. Recall # B-1258-09
CODE
Unit: W089808462558 (Part 1 and 2)
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Sterling, VA, by telephone on November 10, 2008 and follow letter dated November 21, 2008. Firm initiated recall is complete.
REASON
Blood products, labeled “leukoreduced”, but which had not undergone leukoreduction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
DC, VA
___________________________________
PRODUCT 
Red Blood Cells. Recall # B-1259-09
CODE
Unit: W089808462616)
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Sterling, VA, by telephone on November 7, 2008 and by follow-up letter dated November 20, 2008. Firm initiated recall is complete.
REASON
Blood product, labeled “leukoreduced”, but which had not undergone leukoreduction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
__________________________________
PRODUCT 
1) Red Blood Cells. Recall # B-1260-09;
2) Platelets Pooled Leukocytes Reduced. Recall # B-1261-09
CODE
1) Unit: 6753273;
2) Unit: 1012318
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by letter dated June 2, 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
OH

___________________________________
PRODUCT 
Source Plasma. Recall # B-1262-09
CODE
Units: 0170266057, 0170268313, 0170268701, 0170269514, 0170260757, 0170271109, 0170271968, 0170272362, 0170273383, 0170273819, 0170274874, 0170275671, 0170276235, 0170276824, 0170278188, 0170279439, 0170279936, 0170281025, 0170281667, 0170282252, 0170283510, 0170285021, 0170285433, 0170286189, 0170287173, 0170287685, 0170288538, 0170288944, 0170290322, 0170291134, 0170292072, 0170292429, 0170293285, 0170293704, 0170294418, 0170295119, 0170295905, 0170296929, 0170297254, 0170298085, 0170298507, 0170299289, 0170300464, 0170301287, 0170301666, 0170307259, 0170308827, 0170310119, 0170310424, 0170311258, 0170311652, 0170312541, 0170312960, 0170313712, 0170314569, 0170316153, 0170319642, 0170320379, 0170327386, 0170327780, 0170329523
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc, Laredo, TX, by fax on August 20, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a body piercing within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
61 units
DISTRIBUTION
CA, Spain

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1219-09
CODE
Unit: 6556555
RECALLING FIRM/MANUFACTURER
Carter BloodCare/WE & Lela I Stewart Blood Center, Inc, Tyler, TX, by telephone on November 5, 2005. Firm initiated recall is complete.
REASON
Blood product, that was not quarantined after receiving information concerning post-donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1242-09
CODE
Unit: 9006975
RECALLING FIRM/MANUFACTURER
Atlanta Blood Services, Atlanta, GA, by telephone on March 12, 2008 and by letter dated March 12, 2008. Firm initiated recall is complete.
REASON
Blood product, which did not meet the requirement for red blood cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1246-09
CODE
Unit: 6173328
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood & Tissue Center, Austin, TX, by telephone on February 7, 2007. Firm initiated recall is complete.
REASON
Blood product, which may have been exposed to unacceptable temperatures during shipment, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1255-09
CODE
Units: W035809086904 (Part A and B)
RECALLING FIRM/MANUFACTURER
Blood Services, Inc, Mather, CA, by telephone on February 4, 2009. Firm initiated recall is complete.
REASON
Blood products, with an unacceptably low red cell recovery rate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________
PRODUCT 
Zimmer TM-400 Broach Handle; Part No. 96-210-10001. The product is a surgical instrument for use in conjunction with Zimmer TM-400 Trabecular Metal implants during spinal surgery. The Broach Handle threads onto various broaches and trial implants. The handle with these broaches or trials attached is used to prepare and measure a vertebral space to accept a TM-400 Trabecular Metal implant. Recall # Z-1246-2009
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer Inc, Warsaw, IN, letter dated April 29, 2009.
Manufacturer: Zimmer Trabecular Metal Technology, Inc, Parsippany, NJ. Firm initiated recall is ongoing.
REASON
The broach handle may fracture at the threaded tip during use, which would result in surgical intervention to retrieve the broach or the trial as the threaded tip fragment prevents attachment of another handle to retrieve the device.
VOLUME OF PRODUCT IN COMMERCE
435 units
DISTRIBUTION
Nationwide, Austria, Australia, Belgium, Canada, Finland, Germany, Greece, Korea, South Africa, Sweden, Switzerland, Taiwan and the United Kingdom
___________________________________
PRODUCT 
1) Genicon, RX Only, Sterile EO. Catalog Number 700-005-010, 5MM. A suction irrigation device. This device is used in conjunction with an insufflator during laparoscopic surgery to provide suction and irrigation to the surgical site. The suction irrigation product contains a trumpet valve handpiece that fits into either the left or right hand. The double sealing valve system provides operation of the suction and irrigation functions while preventing fluid leakage. Recall # Z-1406-2009;

2) Genicon, RX Only, Sterile EO. Catalog Number 700-010-005, 10MM (Foreign Distribution Only). A suction irrigation device. This device is used in conjunction with an insufflator during laparoscopic surgery to provide suction and irrigation to the surgical site. The suction irrigation product contains a trumpet valve handpiece that fits into either the left or right hand. The double sealing valve system provides operation of the suction and irrigation functions while preventing fluid leakage. Recall # Z-1407-2009
CODE
1) Lot Numbers: 441071225, 434071227, 434080237 and 434080373;
2) Lot Number 434071224
RECALLING FIRM/MANUFACTURER
Genico, Inc, dba Genicon, Winter Park, FL, by e-mail and fax on May 8, 2008. Firm initiated recall is ongoing.
REASON
Genicon is recalling the Genicon Disposable Suction Irrigation 5mm 700-005-010 and 10mm 700-005-005 Tube Sets. The caps on the trumpet valves of the devices could fall off, resulting in the malfunction of the Suction Irrigation Device.
VOLUME OF PRODUCT IN COMMERCE
3,260 units
DISTRIBUTION
MO, IA, United Kingdom, Netherlands and United Arab Republic
___________________________________
PRODUCT 
1) BrainLab Micro-Multileaf-Collimator, model 41600; The mMLC is intended to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from access radiation; Model 41600. Z-1544-2009;

2) BrainLab M3 Micro-Multileaf-Collimator for Varian Type III with MLC, model 41600-3; The mMLC is intended to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from access radiation; Model 41600-3. Recall # Z-1545-2009;

3) BrainLab M3 Micro-Multileaf-Collimator for Siemens Mevatron Digital Type III with MLC, model 41600-5, -5 A; The m MLC is intended to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from access radiation; Model 41600-5A. Recall # Z-1546-2009;

4) BrainLAB M3 Micro-Multileaf-Collimator for Elekta/Philips Type III with MLC, model 41600-06, -6 A; The m MLC is intended to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from access radiation. Model 41600-6A; Recall # Z-1547-2009
CODE
1) Serial Numbers: 02-027-41600, 02-025-41600, 01-012-41600, 41600-093-00, 41600-001, 01-039-41600, 01-043-41600, 01-004-41600, 01-007-41600, 01-019-41600, 02-040-41600, 01-036-41600 and 02-008-41600;

2) Serial Numbers: 06-99333-41600-3, 03-009-41600-3, 41600-3/35396, 41600-017, 41600-3/28593, 41600-064-00, 03-023-41600-3, 41600-056-99, 41600-075-00, 41600-060-00, 41600-3/36524, 05-55140-41600-3, 41600-059-99, 05-60360-41600-3, 41600-3/27334, 41600-078-00, 41600-3/21564, 03-024-41600-3, 41600-3/33271, 41600-022, 41600-3/34734, 41600-051, 41600-018, 03-011-41600-3, 01-033-41600, 41600-084-00, 01-038-41600, 41600-3/27296, 41600-026, 00-098-41600, 01-031-43500, 41600-3/20311, 41600-050, 41600-3/29308 and 41600-024 Refurbished to1848808001;

3) Serial Number 05-46974-41600-5A;

4) Serial Number 41600-6A/24143
RECALLING FIRM/MANUFACTURER
Brainlab AG, Kirchheim B Muenchen, Germany, by letter dated March 19, 2009. Firm initiated recall is ongoing.
REASON
The Integrated Multileaf-Collimator (MLC) of the linear accelerator could interfere with the intended conformal fields of the BrainLab m3 micro-Multileaf-Collimator (mMLC) during patient treatment.
VOLUME OF PRODUCT IN COMMERCE
50 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expiration: July 14, 2009; Catalog Number: 4468. Recall # Z-1553-2009
CODE
Lot Number: 4468-071408
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cyberkinetics Neurotechnology Systems, Inc, Foxboro, MA, by e-mail on February 4, 2009.
Manufacturer: Blackrock Microsystems (DBA), Salt Lake City, UT. Firm initiated recall is ongoing.
REASON
Sterility of product cannot be assured.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Siemens Stratus CS Acute Care Troponin I CalPak. In vitro product intended to be used for calibration of the cardiac troponin I method on the Stratus CS analyzer. Recall # Z-1555-2009
CODE
Lot Numbers: 637218002 (expired immediately), 637281002 (expired immediately), 637350002 (expired immediately), 638035002 (expired June 4, 2008); and 638105002 (expired August 14, 2008)
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc, Newark, DE, by letter dated April 29, 2008. Firm initiated recall is complete.
REASON
The firm received and confirmed that some lots of Cardiac Troponin I (cTnl) CalPaks (CCTNI-CR) may exhibit calibration issues that cause lower than typical signal during calibration with the current population of cTnl TestPaks (CCTNI). This issue may result in failed calibrations due to "Slope Error" messages or falsely elevated patient sample and quality control (QC) results on calibrations that are within the calibration guidelines (no Slope Errors).
VOLUME OF PRODUCT IN COMMERCE
3,257 cartons
DISTRIBUTION
Nationwide, United Arab Emirates, Austria, Bermuda, Belize, Canada, Germany, Egypt, India, Japan, Saudi Arabia, and Bengal
___________________________________
PRODUCT 
Dental Application on the Extended Brilliance Workspace v4.0 and v4.0.1. a) Model #455011202691 for Computed Tomography (CT); b) Model #455011002031 for Nuclear Medicine (NM). The "Extended Brilliance Workspace (EBW)" Dental Application v4.0 and v4.0.1 is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall # Z-1568-2009
CODE
a) Serial Number: 5754, 6437, 6467, 6543, 6835, 7253, 7576, 7579, 7639, 8756, 8757, 10102, 10103, 10108, 10109, 10111-10114, 10116, 10117, 10119, 10120, 10122-10126, 10128, 10129, 10132, 10134-10144, 10146, 10151, 10154, 10158, 10161, 10163, 10167, 10173, 10174, 10175, 10179-10184, 10195, 10322, 10356, 10361, 10427, 10437, 10449, 10456, 10484, 10492, 10537, 10598, 10604, 10668, 10690, 10722, 10745, 10770, 10778, 10821, 10822, 10841, 10889, 10906, 10938, 10939, 10940, 10943, 10945, 10952, 10965, 10998, 11025, 11037, 11054, 11065, 11085, 11089, 11099, 11102, 11103, 11104, 11113, 11121, 11127, 11140, 11148, 11149, 11151, 11152, 11168, 11169, 11174, 11229, 11230, 11232, 11260, 11274, 11280, 11282, 11291, 11314, 11339, 11341, 11557, 11564, 11577, 11585, 11610, 11620, 11630, 11631, 11633, 11663, 11667, 11668, 11708, 11742, 11744, 11745, 11751, 11752, 11754, 11758, 11766, 11780, 11783, 11787, 11790, 11792, 11795, 11797, 11803, 11804, 11807, 11809, 11810, 11812, 11813, 11832, 11834, 11838, 11839, 11841, 11844, 11846, 11848, 11850, 11852, 11853, 11854, 11855, 11858, 11859, 11862, 11863, 11864, 11865, 11870, 11872, 11877, 11879, 11884, 11886, 11888, 11892, 11897, 11921, 11922, 11928, 11937, 11981-12064, 12071, 12073-12099, 12105, 12109, 12138, 12139, 12140, 12144, 12146, 12149, 12152, 12156, 12164, 12166, 12168, 12179, 12201, 12203, 12250-12259, 12272, 12276-12299, and 12450-12453; b) Serial Number: 4123, 7003, 7004, 7005, 7013, 7016, 7052, 7061, 7066, 7145, 7060, 7050, 7011, and 7020
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc, Cleveland, OH, by letter dated April 27, 2009. Firm initiated recall is ongoing.
REASON
Philips Healthcare has recalled the Dental Application on the Extended Brilliance Workspace v4.0 and v4.0.1 due to the fact that when images are saved or filmed that contain the Curved Multi-planar Reformation Section (cMPRS) views that were created with a short curve the Right/Left annotations will be reversed.
VOLUME OF PRODUCT IN COMMERCE
417 units
DISTRIBUTION
Nationwide and Africa, Albania, Austria, Australia, Bangladesh, Belgium, Brazil, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Holland, India, Iraq, Israel, Italy, Japan, Korea, Lithuania, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Puerto Rico, Russia, Singapore, Spain, South Africa, Sweden, Switzerland, Syria, Tahiti, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and Venezuela

END OF ENFORCEMENT REPORT FOR JULY 15, 2009

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