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F.d.a Recalls For This Week

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I get these notices from the FDA...just passing the info along..

May 20, 2009

09-20

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

___________________________________

PRODUCT

Pimento Cheese Spread packaged in 5 pound plastic tubs, 2 per case, under the following brands: St. Clair, Sysco Classic and Ron's Home Style Foods. Recall # F-234-9

CODE

5/1/2009

RECALLING FIRM/MANUFACTURER

St. Clair Food, Inc. Memphis, TN, by telephone and e-mails on January 12, 2009. Firm initiated recall is complete.

REASON

Product is manufactured under insanitary conditions, which can lead to micro-contamination.

VOLUME OF PRODUCT IN COMMERCE

4,040 lbs.

DISTRIBUTION

TN, TX, AR, KY

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

___________________________________

PRODUCT

Harvest of Eden cut green beans, net wt. 6 lb. 6 oz, Product of China; UPC 1930351300. Recall # F-232-9

CODE

Case codes 08111011789M, 08111011789B, 0812132064C, 08110711786M, 08110711786D, 08110911788H and 0812142065P. The can code information is not available, but all cans imported into the U.S. are included in this recall.

RECALLING FIRM/MANUFACTURER

Recalling Firm: McFarling Foods, Inc. Indianapolis, IN, by email and telephone on March 20, 2009.

Manufacturer: Zhangzhou Tongfa Foods Industry, Co. Jiaomei Town, China. Firm initiated recall is complete.

REASON

There may be dead worms mixed in with the product.

VOLUME OF PRODUCT IN COMMERCE

269 cases

DISTRIBUTION

IN and KY

___________________________________

PRODUCT

Cool River *** Bebidas Naturales *** Mezela de Frutas *** Two sizes: 16 oz. and 64 oz. Recall # F-233-9;

CODE

Lots # 810 Exp Date 12/15/2008, 811 Exp Date 12/15/2008 , 813 Exp Date 12/15/2008, 814 Exp Date 12/15/2008, 817 Exp Date 12/15/2008, 818 Exp Date 12/15/2008, 819 Exp Date 1/15/2009, 820 Exp Date 1/3/2009, 821 Exp Date 3/2/2009, 822 Exp date 3/6/2009, 823 Exp Date 3/7/2009 , 824 Exp Date 3/8/2009, 827 Exp Date 3/15/2009, 828 Exp Date 3/16/2009 , 829 Exp Date 3/19/2009 , 830 Exp Date 2/19/2009, 831 Exp Date 2/21/2009, 833 Exp Date 2/23/2009, 834 Exp Date 2/24/2009, 835 Exp Date 2/28/2009, 836 exp date 2/29/2009, 837 Exp Date 2/31/2009 , 839 Exp Date 3/5/2009, 842 Exp Date 3/10/2009, 843 Exp Date 3/11/2009, 844 Exp Date 3/13/2009, 846 Exp Date 3/17/2009, 847 Exp Date 3/18/2009, 848 Exp Date 3/19/2009, 851 Exp Date 3/24/2009, 854 Exp Date 4/2/2009, 855 Exp Date 4/3/2009, 856 Exp Date 4/5/2009, 857 Exp Date 4/8/2009, 859 Exp Date 4/11/2009 ,and 860 Exp Date 4/16/2009

RECALLING FIRM/MANUFACTURER

San Mar Manufacturing Corp. Catano, PR, by visit beginning on December 17, 2008. Firm initiated recall is complete.

REASON

Fruit Punch labeled as sugar-free actually contains corn fructose.

VOLUME OF PRODUCT IN COMMERCE

49,440 bottles

DISTRIBUTION

PR

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

___________________________________

PRODUCT

a) Daytrana (methylphenidate transdermal system), 10 mg, 30 patches per box, Rx only, NDC 54092-552-30. Recall # D-410-2009;

:) Daytrana (methylphenidate transdermal system), 15 mg 30 patches per box, Rx only, NDC 54092-553-30. Recall # D-411-2009;

c) Daytrana (methylphenidate transdermal system), 20 mg 30 patches per box, Rx only, NDC 54092-554-30. Recall # D-412-2009;

d) Daytrana (methylphenidate transdermal system), 30 mg 30 patches per box, Rx only, NDC 54092-555-30. Recall # D-413-2009

CODE

a) Lot numbers: 2570611 (exp 04/30/2009), 2617011 (exp 06/30/2009), 2617111 (exp 07/31/2009), 2656911 (exp 08/31/2009) 3014511 (exp 05/31/2010), 2657212 (exp 08/31/2009), 3073511 (exp 05/31/2010), 2657211 (exp 08/31/2009), 2616311 (05/31/2009), 2617211 (06/30/2009);

:( Lot numbers: 2572011 (exp 05/31/2009), 2732811 (exp 09/30/2009), 27328111 (exp 09/30/2009);

c) Lot numbers: 2617811 (exp 06/30/2009), 2624711 (exp 06/30/2009), 2625211 (exp 7/31/2009), 3051911 (exp 05/31/2010), 31947 (exp 07/31/2010), 31949 (exp 07/31/2010), 31951 (07/31/2010), 33041 (exp 09/30/2010), 33042 (exp 09/30/2010), 34172 (exp 12/31/2010);

d) Lot numbers: 2572411 (exp 05/31/2009), 2572611 (exp 05/31/2009), 2573211 (exp 06/30/2009), 2573311 (exp 06/30/2009), 2573411 (exp 06/30/2009), 2652411 (exp 08/31/2009), 2733111 (exp 09/30/2009), 2737411 (exp 10/31/2009), 2750111 (exp 11/30/2009), 3015011 (exp 05/31/2010), 3015311 (exp 05/31/2010), 31739 (exp 06/30/2010), 31920 (exp 06/30/2010), 31921 (exp 06/30/2010), 31922 (exp 06/30/2010), 31923 (exp 06/30/2010), 2733211 (09/30/2009)

RECALLING FIRM/MANUFACTURER

Recalling Firm: Shire PLC, Wayne, PA, by press release and letter on March 20, 2009.

Manufacturer: Noven Pharmaceuticals, Inc. Miami, FL. Firm initiated recall is ongoing.

REASON

Defective delivery system (mechanical [peel force out of specification).

VOLUME OF PRODUCT IN COMMERCE

245,204 boxes

DISTRIBUTION

CA, FL, IL, LA, MI, MN, MO, ND, NY, OH, PA, SC, and VT

___________________________________

PRODUCT

Klonopin Wafers (clonazepam orally disintegrating wafers) CIV, 2 mg, carton of 60 blistered wafers (10 x 6), Rx only. NDC 0004-0283-22. Recall # D-414-2009

CODE

Lot number: U5011, Exp. Date 3/2010

RECALLING FIRM/MANUFACTURER

Recalling Firm: Hoffmann La Roche, Inc. Nutley, NJ, by letters on March 26, 2009.

Manufacturer: Cardinal Health, Swindo, UK. Firm initiated recall is ongoing.

REASON

Subpotent

VOLUME OF PRODUCT IN COMMERCE

957 units

DISTRIBUTION

Nationwide

___________________________________

PRODUCT

Sore Throat Lozenges, Pastillas para el dolor de la garganta, (Benzocaine 6mg and Menthol 10mg), 100 Lozenges. UPC Code 0 92265 08450 5. Recall # D-415-2009

CODE

Codes are for products manufactured from 3/3/2008 through 3/24/2009 as follows: C0038, C0198, D0088, E0058, F0248, I0084, K0198 and B02690511

RECALLING FIRM/MANUFACTURER

First Aid Only Inc. Vancouver, WA, by telephone and letter beginning on April 3, 2009. Firm initiated recall is ongoing

REASON

Misbranded; product labeled to contain Benzocaine and Menthol actually contains Hexylresorcinol.

VOLUME OF PRODUCT IN COMMERCE

726 boxes each containing 100 lozenges

DISTRIBUTION

Nationwide

___________________________________

PRODUCT

a) Sterile Vancomycin Hydrochloride USP, Sterile Lyophilized Powder, Equivalent to 5 g Vancomycin, Pharmacy Bulk Package (100-ml vials)-Not for Direct Infusion, For Intravenous Use, NDC 0409-6509-01, Rx only. Recall # D-416-2009;

:angry: Sterile Vancomycin Hydrochloride, USP, For Intravenous Use, Sterile Powder packaged in a flip top vial, Equivalent to 1 g Vancomycin, Lyophilized, 10 units per immediate carton, 5 cartons per shipping case, Rx only, NDC 0409-6533-01. Recall # D-417-2009;

c) A-Hydrocort (Hydrocortisone Sodium Succinate) for Injection, USP, 100 mg, Sterile Powder for Injection packaged in a single-dose vial, Hydrocortisone Activity/2 mL (when mixed), Rx only, NDC 0409-4856-05, packaged in immediate cartons of 10 units, 10 cartons per shipping case. Recall # D-418-2009

CODE

a) Lot 72-030-DD, Exp. 1 Sep 2010, Lot 69-455-DD, Exp. 1 Jun 2010, and 70-170-DD, Exp. 1 Jul 2010;

:blink: Lot 65-060-DD, Exp. 1 May 2010, and Lot 64-006-DD, Exp. 1 Apr 2010;

c) Lot 59-560-DD, Exp. 1May 2009

RECALLING FIRM/MANUFACTURER

Recalling Firm: Hospira Inc. Lake Forest, IL, by letters dated February 25, 2009 and e-mails on February 27, 2009.

Manufacturer: Hospira Inc. Mc Pherson, KS. Firm initiated recall is ongoing.

REASON

The sterility of the stoppers used on sterile products was potentially compromised.

VOLUME OF PRODUCT IN COMMERCE

a) 61,290 vials; :huh: 237,800 vials; c) 9,470 vials

DISTRIBUTION

Nationwide

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