DECEMBER 2009

WEEK ENDING DECEMBER 19

PRODUCT  Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single Entity Amphetamine Product), CII, 20mg tablets, 100 count bottles, Rx only, NDC 0555-0973-02; Tablets are oval shaped and peach colored, debossed with b/973 on one side and 2/0 on the other side. R
CODE Lot 311756, Exp 05/12
RECALLING FIRM/MANUFACTURER
Barr Laboratories Inc., Forest, VA
REASON
Tablet Thickness: Some tablets exceed weight specifications and may deliver more than the intended dose.
VOLUME OF PRODUCT IN COMMERCE
9,826 bottles
DISTRIBUTION Nationwide

PRODUCT  DERMADROX OINTMENT (aluminum hydroxide) pH Balanced Skin Protectorant, Net wt 4 oz. (113 gm) jars, NDC 54162-221-04. 
CODE Lot # 906135, Cat # DA4, EXP. Date 07/11
RECALLING FIRM/MANUFACTURER
Geritrex Corp., Mount Vernon, NY,
REASON
Mispacked; boxes labeled to contain jars of Dermadrox Ointment may also contain jars of Hydrophor Ointment.
VOLUME OF PRODUCT IN COMMERCE
55 cases (660 pieces)
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. NDC 0046-0938-09, One EZ-DIAL Dispenser contains 28 cream PREMPRO Tablets containing 0.3 mg of the conjugated estrogens found in PREMARIN & 1.5 mg of medroxyprogesterone acetate. 
CODE Lot D57070, Exp September 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals Philadelphia, PA
Manufacturer: Pfizer, Rouses Point, NY and Wyeth Pharmaceuticals Co., Guayama, PR. 
REASON
Failed Dissolution Specification
VOLUME OF PRODUCT IN COMMERCE
21,060 cartons of 3 dispensers
DISTRIBUTION Nationwide

Vicks Dayquil Cold & Flu Liquicaps 

Name of Product: Vicks Dayquil Cold & Flu 24-Count Bonus Pack Liquicaps

Units: About 700,000 packages

Manufacturer: The Procter & Gamble Co., of Cincinnati, Ohio

Hazard: The cold and flu medicine contains acetaminophen and is not in child-resistant packaging and lacks the statement, “This Package for Households Without Young Children,” as required by the Poison Prevention Packaging Act. This medicine could cause serious health problems or death to a child if several of the capsules are swallowed.

Description: The recall involves Vicks Dayquil Cold & Flu 24-Count Bonus Pack Liquicaps. The medicine comes in orange packaging with the green Vicks symbol and has the following UPC#: 3 23900 01087 1. No other Vick’s product is included in this recall.

Sold at: Drug stores, grocery stores and other retailers nationwide between September 2008 and December 2009 for about $5.

Remedy: Consumers should keep this product out of the reach of children. Consumers who purchased the product with the expectation that it would be in child-resistant packaging can contact Procter & Gamble for a full refund or a replacement coupon. Adult consumers can continue to use the product as directed.

Consumer Contact: For additional information, contact Procter & Gamble at (800) 251-3374 between 9 a.m. and 6 p.m. ET Monday through Friday or log on to their Web site at www.vicks.com

The Medicines Company Issues a Recall for Certain Lots of Cleviprex® That May Contain Particulate Matter 

The Medicines Company (NASDAQ: MDCO) is recalling eleven (11) lots of Cleviprex ® (clevidipine butyrate) injectable emulsion due to the potential presence of visible particulate matter. The affected Cleviprex lots are 61-978-DW, 61-979-DW, and 61-980-DW, Exp. 01/2010; 68-404-DJ, 68-405-DJ, and 68-406-DJ, Exp. 08/2010; 69-830-DJ, 63-385-DJ, 63-386-DJ, and 63-266-DJ, Exp 03/2011; and 64-453-DJ, Exp. 04/2011. No other lots are affected by this recall.

The particulate matter comprises sub-visible inert stainless steel particles of around 2.5 microns. When present in low numbers as observed, particles of this size are not known to constitute a health hazard. 

Anyone with inventory from the affected lots of Cleviprex should arrange for its return through their pharmaceutical wholesaler/distributor. Unaffected product from lots 68-407-DJ, 68-408-DJ, 71-101-DJ and 71-106-DJ is being shipped to wholesalers and can be ordered by hospitals.

For medical inquiries, adverse event reporting or quality issues related to Cleviprex, please contact The Medicines Company Medical Information at 1-888-977-6326 Monday to Friday 8:00am-5:30pm EST or cleviprexrecall@themedco.com.

WEEK ENDING DECEMBER 12

Atlas Operations, Inc. Issues a  Recall of Specific Lots of Sexual Enhancement Products Marketed as Dietary Supplements 

Atlas Operations, Inc. is recalling of the company's dietary supplements for sexual enhancement sold under Lot Numbers 494, 520C, 520B, 520A, 520, 521, 705, 706, 779 & 807.

These products are currently being sold as a dietary supplement throughout the U.S.  A lab analyses found that the products tested from certain batches of the following products Rock Hard T12-705-09, R52-705-09, 72 hrs B54-708-09, Stamin It R2-705-08, Finally On Demand R26-706-09, R27-706-09, Sexual Surge H49-705-09, Staminil T25,705-09, Virect T29-705-09  contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED) making these products an unapproved drug. The active drug ingredient is not listed on the product label.

Dietary Supplements Sold Under Lot Numbers 

**Lot numbers may or may not contain dashes. The first three and last two digits and letters are insignificant.
***If you have a product with a different name but the same lot number please contact Atlas Operations, Inc. for recall instructions.

We urge consumers who have purchased these products to discontinue their use and return to their place of purchase.  You may also return products directly to Atlas Operations.  

Customers can call Atlas Operations at 1-800-466-4444 Monday through Friday from 9:00 am - 5:00 pm EST for instructions on the return and refund process.

PRODUCT Propofol Injectable Emulsion 1%, 200 mg/20 mL, (10 mg/mL), 20 ml vials, NDC on vials is 0703-2856-01, shipped in packages containing 25 vials, NDC on package is 0703-2856-04. 
CODE
Lot numbers: 31308134B exp 8/2011, 31308278B exp 8/2011, 31308279B 8/2011, 31308350B exp 9/2011, 31308659B exp 9/2011, 31308784B exp 9/2011, 31308785B exp 9/2011, and 31309201B exp 9/2011
RECALLING FIRM/MANUFACTURER
Teva Pharmaceuticals USA, Inc., Sellersville, PA,
REASON
Lack of Sterility Assurance: The product was manufactured on equipment found to be contaminated with microbiological organisms.
VOLUME OF PRODUCT IN COMMERCE
1,138,800 vials
DISTRIBUTION Nationwide

Bayer Consumer Care Recalls One Lot of Combination Package of Alka-Seltzer Plus® Day & Night Cold Formula Liquid Gels

Bayer’s Consumer Care division has begun a recall of a single product lot of the combination package of Alka-Seltzer Plus® Day & Night Cold Formula Liquid Gels. Bayer initiated the recall after identifying that the labeling on the foil blister card of certain packages within the lot (less than 4 percent) were printed with the label reversed. All individual liquid filled capsules are imprinted correctly.

The affected Alka-Seltzer Plus product lot number can be found on both the interior blister package (in black text adjacent to the expiration date) as well as on the exterior carton containing the blister packaging (embossed on the side panel under the Bayer logo)

• Product Name: Alka-Seltzer Plus Day & Night Liquid Gels
• Package size: 20 liquid filled capsules per carton (12 day formulation capsules and 8 night formulation capsules)
• UPC#: 016500537779
• Lot #: 296939L
• Expiration: 5/11

This product was sold only in the U.S. at retail outlets nationwide.

Consumers should contact our Consumer Relations Call Center at 1(800) 986-3307 (available Monday - Friday 8:30 AM - 5:30PM eastern standard time.) 

WEEK ENDING DECEMBER 5

PRODUCT S-DROL tablets, 60 tablets per bottle, UPC 8 272386 000376,
CODE Lot # 810481, Exp 01/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nutracoastal Trading, LLC, Freeport, NY, by telephone on July 27, 2009 and by press release on July 28, 2009. 
Manufacturer: Eniran Manufacturing, Farmingdale, NY. Firm initiated recall is ongoing. 
REASON
Marketed Without an Approved NDA/ANDA: Product contains desoxymethyltestosterone, an anabolic steroid, making it an unapproved new drug.
VOLUME OF PRODUCT IN COMMERCE
1688 bottles
DISTRIBUTION Nationwide

PRODUCT FENOLDOPAM MESYLATE INJECTION, USP 20 mg/2 mL, (10mg/mL), Rx ONLY, Vial, NDC 55390-072-01,
CODE Lot # 1212849; Expiration Date, 05/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bedford Laboratories, Bedford, OH,
Manufacturer: Ben Venue Laboratories, Inc., Bedford, OH.
REASON
Superpotent; in-process testing
VOLUME OF PRODUCT IN COMMERCE
517/20mg/2mL vials
DISTRIBUTION Nationwide

PRODUCT Colic Calm, a homeopathic liquid, oral suspension, packaged in a 2 oz. amber glass bottle with a black cap. OTC. NDC 13992-001-01. Product contains: -aloe Socotrina (aloe) 3x, -carbo vegetabilis (vegetable charcoal) 1x, -carum carvi (caraway) 3x, -chamomilla (chamomile) 3x, -foeniculum vulgare (fennel) 3x, -melisa officinalis (lemon balm) 3x, -mentha piperita (peppermint) 3x, -prunus spinosa (black thorn) 3x, -zingiber officinale (ginger) 3x, -vegetable glycerin in water base.
CODE Lot number 0259, manufacturer date 02/23/09
RECALLING FIRM/MANUFACTURER
Genesis Pharmaceutical, Inc., Henderson, NV,
REASON
Yeast contamination
VOLUME OF PRODUCT IN COMMERCE
2,589 units
DISTRIBUTION CA, NV

PRODUCT Sertraline Tablets, 50mg bottles of 90, NDC 6252-534-90,
CODE Lot: (L) BH54A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cobalt Laboratories, Bonita Springs, FL,
Manufacturer: Legacy Pharmaceutical Packaging LLC, Earth City, MO.
REASON
Incorrect medication guides shipped with product
VOLUME OF PRODUCT IN COMMERCE
101 Shipping Cartons
DISTRIBUTION FL, OH, NE, MI, OK, IL

PRODUCT PREMPRO"(conjugated estrogens/medroxyprogesterone acetate tablets) 0.3 mg/1.5 mg, 28 tablet EZ-DIAL dispenser (NDC 0046-0938-08), 3 EZ-DIAL dispensers per package (NDC 0046-0938-09), Rx only,
CODE Lot: C95001, Exp. July 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals, Philadelphia, PA,
Manufacturer: Wyeth Pharmaceuticals Co., Guayama, PR.
REASON
Failed USP Dissolution Test Requirements: conjugated estrogens 6 month stability.
VOLUME OF PRODUCT IN COMMERCE
23,760 Cartons of 3 Dispensers
DISTRIBUTION Nationwide