JUNE 2008

WEEK ENDING JUNE 7

PRODUCT
a) Family Dollar Milk of Magnesia Mint Flavor, Magnesium hydroxide 400mg, 12 fl. oz. bottles, 
b) Family Dollar Milk of Magnesia Cherry Flavor, Magnesium hydroxide 400mg, 12 fl. oz. Bottles, 
CODE
a) Lot Numbers: 32393, 32394, 32395, 32396, 32711, 32712, 33288, 33289;
b) Lot Numbers: 32354, 32355, 32356, 32360, 32361, 32362, 32713, 32714, 33290, 33291
RECALLING FIRM/MANUFACTURER Aaron Industries Inc., Lynwood, CA,
REASON Misbranded; dosing instructions for use as a Laxative for children 2 to 5 years incorrectly states 1-3 tablespoons instead of 1-3 teaspoons once a day.
VOLUME OF PRODUCT IN COMMERCE 74,314 units
DISTRIBUTION Nationwide

PRODUCT Effexor XR Extended-Release Capsules, 150mg, 90 count bottles, Rx Only, NDC 0008-0836-22, 
CODE Lot: C47303S Exp. Date: August 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Ayerst Laboratories, Philadelphia, PA, Manufacturer: Wyeth Pharmaceuticals Company, Guayama, PR. 
REASON Presence of Foreign Substance; handwritten ink numbers were placed on the outside of empty capsules shells during the manufacturing process of the bulk capsules.
VOLUME OF PRODUCT IN COMMERCE 1,930 bottles of 90 capsules each
DISTRIBUTION Nationwide

WEEK ENDING JUNE 14

Leiner Health Products Issues Recall for Undeclared Allergens in Liquimax® Multivitamin

Leiner Health Products Inc. ("Leiner" or "the Company")  is recalling its 32 ounce plastic bottles of Liquimax Complete Nutrition Multivitamin Formula, labeled with UPC Code 7497052290, 7497023607, or 7497023696 because the product may contain undeclared fish (not shellfish), tree nuts (almonds, pecans and/or walnuts), and wheat. 

The recalled Liquimax Multivitamin was distributed nationwide in retail stores.

Consumers allergic to the above listed allergens are advised not to consume the product and are asked to call 1-800-533-8482 for a full refund. This number can be contacted 24 hours a day with representatives available Monday through Friday between the hours of 8 am and 5 pm (EDT).

ETHEX Corporation Recalls a Single Lot of Morphine Sulfate 60 mg Extended Release Tablets Due to the Potential for Oversized Tablets

ETHEX Corporation is recalling a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by ETHEX Corporation under an "ETHEX" label between April 16th and April 27th of 2008. No other dosage strength, nor any other lot of the 60 mg strength is affected by this recall.

The product is a white oval tablet with "60" on one side, and "E" on the reverse.

Any customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-321-1705, or fax to ETHEX Customer Service at 314-646-3751 or sent via email to: customer-service@ethex.com with representatives available Monday through Friday, 8 am to 5 pm CST.

ETHEX Corporation Recalls Specific Lots of 30 mg. and 60 mg. Morphine Sulfate Extended Release Tablets 

ETHEX Corporation is recalling specific additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, as a precaution, due to the possible presence of oversized tablets.  Oversized tablets may contain as much as two times the labeled level of active morphine sulfate.  The recalled lots were distributed by ETHEX Corporation under an “ETHEX” label between June 2006 and May 2008.  The lot numbers involved in the recall are:

Morphine Sulfate ER 30mg Tablet/NDC # 58177-320-04:  Lots 75090, 77846, 77847, 80048, 83320, 89661, 89665, 90252 through 90258, and 93284

Morphine Sulfate ER 60mg Tablet/NDC # 58177-330-04:  Lots 91762 (previously reported), 75091, 75092, 77848 through 77851, 82517, 82518, 83333, 83817, 83862, 84111, 84112, 84315, 84900, 85326, 85335, 85807, 86270 through 86276, 87723, 87939, 88007, 89083, 89668, 89669, 89821, 90260 through 90272, and 91763 through 91765.

No report of unexpected side effects or injury has been received.  However, opioids such as morphine, have life-threatening consequences if overdosed.  Those consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure, apnea, and hypotension.

The 60 mg product is a white oval tablet with “60” on one side, and “E” on the reverse.  The 30 mg product is a pink oval tablet with “30” on one side, and “E” on the reverse.   

Any customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-321-1705, or fax to ETHEX Customer Service at 314-646-3751 or sent via email to: customer-service@ethex.com with representatives available Monday through Friday, 8 am to 5 pm CDT.

PRODUCT
a) Thyro-Tab 0.025mg, 150,000-tablet bulk drums intended for repackaging, Rx only,
b) Levothroid (levothyroxine sodium tablets, USP), 25 mcg, 100- and 1,000-tablet bottles, RX only; NDC 0456-1320-01 (100-ct.) and NDC 0456-1320-00 (1,000-ct.),
CODE
a) Lot HA08207, Exp. April 2008; Lot HC13007, Exp. May 2008;
b) Lot 050701 (100-tab.) and 050702 (1,000-tab), both from bulk lot HA08207, Exp. April 2008; Lot 060736 (100-tab.) and 070706 (1,000-tab), both from bulk lot HC13007, Exp. May 2008
RECALLING FIRM/MANUFACTURER Lloyd Inc of Iowa, Shenandoah, IA,
REASON Subpotent; (8-month and 9-month stability intervals)
VOLUME OF PRODUCT IN COMMERCE
3,820,252 bulk Thyro-Tab tablets; 17,681/100-tab. bottles and 632/1,000-tab. bottles Levothroid
DISTRIBUTION Nationwide

PRODUCT Paroxetine Tablets, USP, 20 mg, 100 count bottles, NDC Number: 68382-098-01, 
CODE Lot MG3179, Exp date 5/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zydus Pharmaceuticals USA Inc., Princeton, NJ, 
Manufacturer: Cadila Healthcare Ltd., Ahmedabad, India. 
REASON Mislabeled; bottle labeled as containing Paroxetine 20 mg Tablets actually contain Warfarin 4mg Tablets
VOLUME OF PRODUCT IN COMMERCE 14,256 bottles
DISTRIBUTION Nationwide

PRODUCT Multiret Folic 500 Tablets, ferrous sulfate, 525 mg, 6 x 10 film coated tablets, Rx only, --- Also labeled as Multiret Folic 500 Tablets, Amide Pharmaceutical ---- NDC 52152-048-14 and Multi-Ferrous Folic 500 Tablets, NDC 0677-0990-06, 
CODE
NDC 0677-0990-06; Lot 06358A1; Exp. date: Apr.08;
NDC 52152-048-14: Lot numbers: 60358A2, Exp. date: Apr. 08; Lot 60358A3, Exp. date Apr 08; Lot 60358A4, Exp. Apr 08; Lot 60633A1, Exp. Jul 08; Lot 60633A2, Exp. Jul 08; Lot 60823A1, Exp. Sep 08; Lot 60823A2, Exp. Jul 08; Lot 60823A3, Exp. Spe 08; Lot 70065A1, Exp. Jan 09; Lot 70065A2, Exp. Jan 09;
Lot Numbers 70254A1, Exp Mar 09; Lot 70254A2, Exp. Mar 09; Lot 70607A1, Exp Jul. 09; Lot 70819A1, Exp Nov. 09 60358A1 Apr-08 60358A2 Apr-08 60358A3 Apr-08 60358A4 Apr-08 60633A1 Jul-08 60633A2 Jul-08 60823A1 Sep-08 60823A2 Sep-08 60823A3 Sep-08 70065A1 Jan-09 70065A2 Jan-09 70254A1 Mar-09 70254A2 Mar-09 70607A1 Jul-09 70819A1 Nov-09
RECALLING FIRM/MANUFACTURER Actavis Totowa LLC, Totowa, NJ
REASON Subpotent; Folic Acid
VOLUME OF PRODUCT IN COMMERCE 15 lots; 169,433 bottles
DISTRIBUTION Nationwide

PRODUCT PREMPRO® (conjugated estrogens/medroxyprogesterone acetate tablets) 0.3 mg/1.5 mg, Rx only, one carton contains 3 EZ-DIAL® Dispensers of 28 tablets each. One EZ-DIAL® Dispenser (NDC 0046-0938-08) contains 28 cream PREMPRO® Tablets containing 0.3 mg of the conjugated estrogens found in PREMARIN® & 1.5 mg of medroxyprogesterone acetate; NDC 0046-0938-09,
CODE Lot: B88216, Exp. 09/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals, Philadelphia, PA, 
Manufacturer: Wyeth Pharmaceuticals, Inc., Rouses Point, NY. REASON Failed USP Dissolution Specifications
VOLUME OF PRODUCT IN COMMERCE 23,832 cartons of 3 Dispensers
DISTRIBUTION Nationwide

PRODUCT Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100 tablet bottles, NDC 67253-263-10 and 1000 tablet bottles, NDC 67253-263-11, Rx only, 
CODE Lot Number 61895A (100's); Lot Number 61895B (1000's)
RECALLING FIRM/MANUFACTURER
Recalling Firm: DAVA Pharmaceuticals, Inc., Fort Lee, NJ, 
Manufacturer: West-Ward Pharmaceutical Corp., Eatontown, NJ. 
REASON Exceeded Impurity Specification; 24 month stability.
VOLUME OF PRODUCT IN COMMERCE 3580 bottles of 100, 592 bottles of 1000
DISTRIBUTION Nationwide

WEEK ENDING JUNE 28

Sage Products Inc. Issues Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation

Sage Products announced a recall of limited lots of 2% Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2% CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia).

The recall includes the following products:

Product was distributed to U.S. hospitals and medical centers nationwide. Affected product was shipped between 4/28/08 and 6/19/08. This voluntary recall is being conducted with the knowledge of the Food and Drug Administration. Sage Products has received no reports of patient injury. No other products from Sage are included in this recall.

Customers who have these products should stop usage, sale and distribution, and should contact Sage Products to coordinate product return and replacement. Additional information is posted at www.sageproducts.com/recall.

Sage Products Customer Service hotline: 1-800-421-6556.

Return unused product to:
Sage Products Inc.
C/O Customer Service Department
3909 Three Oaks Road, Cary, IL 60013