FDA Recalls For May 9, 2012

Recalls reported by FDA for OTC drugs, nutritionals and personal care products.

FOODS - CLASS I
Odwalla Protein Monster, Chocolate Protein, soy and Dairy Protein Shake; 90% Organic Ingredients. Pasteurized, Gluten Free. Packaged in 12 oz and 32 oz re-sealable plastic bottles. Also sold in variety pack exclusively in Costco which contains 10 x 12 oz bottles, 4 of which are chocolate flavor. 25g Protein; 19% DV Potassium, 150% DV Vitamin B6, 150% DV Vitamin B12, 75% DV Calcium. Contains Soy and Milk. Brand Name Package Size Optimum Taste Codes UPC Odwalla Chocolate Protein Monster, 12-oz bottles, UPC 14054 13509; Odwalla Chocolate Protein Monster, 32-oz bottles;; UPC 14054 13504; Odwalla Protein Monster variety pack sold exclusively at Costco, Ten 12-oz bottles, 4 of the bottles are Odwalla Chocolate Protein Monster, UPC 0 14054 26659 6.
Code: All Enjoy by Date Codes prior to and including 23, MAY 2012
Manufacturer:	Odwalla, Inc., Dinuba, CA
Recalled by:	Odwalla Inc., Half Moon Bay, CA, by a press release and letters on April 5, 2012. Firm-initiated recall is ongoing.
Distribution:	Nationwide; approximately 250,000
Reason:	The firm received four separate reports of allergic reactions from individuals who consumed the product. They reported known allergies to peanuts or peanuts and tree nuts.
Recall numbers:	F-1165-2012
DRUGS - CLASS II
1) Up and Up Dye Free Infants Acetaminophen Suspension Liquid Cherry Flavor 160 mg per 5 mL pain reliever/fever reducer a) 1 fl oz,. 30 mL UPC 011673574095, b) 2 fl oz, 60ml, UPC 011673574781, c) Twin Pack - 2 fl oz (60ml), UPC 011673574033, d) Twin Pack Promotion - 2 fl oz UPC 011673257424; 2) Up and Up Dye Free Infants Acetaminophen Suspension Liquid Grape Flavor 160 mg per 5 mL pain reliever/fever reducer 2 fl oz. 60 mL UPC 011673602781.
Code: 1) Units: 574-3426 09/2013 574-3427 09/2013 574-3428 09/2013 574-3439 09/2013 574-3445 09/2013 574-3446 09/2013 574-3502 10/2013 574-3669 11/2013 574-3670 12/2013 574-3671 12/2013 574-3691 12/2013 574-3692 12/2013 574-3714 12/2013 574-3715 12/2013 574-3732 12/2013 374-3760 01/2014 574-3761 01/2014; 2) Unit: 602-3716 12/2013
Manufacturer:	Guardian Drug Co. Inc., Dayton, NJ
Recalled by:	Guardian Drug Co. Inc., by letter on April 16, 2012, and issued a website notification on April 24, 2012. Firm-initiated recall is ongoing.
Distribution:	MN; 260,424 cartons
Reason:	Mislabeling: Infant acetaminophen suspension product labeling was missing the statement "Under 2 years ask doctor" and the weight-based dosing of the label provides for doses that are higher than what has been recommended for children 2 years and older.
Recall numbers:	D-1335-2012; D-1336-2012
DRUGS - CLASS III
Lorazepam Oral Concentrate, USP, 2 mg/mL, Rx Only, 30 mL bottle, NDC 0574-0163-30.
Code: Lot #s: 2010302121, Exp 07/2012; 2010392922, Exp 09/2012; 2010514031, Exp 12/2012; 2011084759, Exp 02/2013; 2011145313, Exp 04/2013; 2011235889, Exp 06/2013
Manufacturer:	Paddock Laboratories, Inc., Minneapolis, MN
Recalled by:	Paddock Laboratories Inc. by letter dated April 4, 2012. Firm-initiated recall is ongoing.
Distribution:	Nationwide; 93,354 bottles
Reason:	Impurities/Degradation Products: This recall has been initiated due to non-conformance to the specification for a specified impurity (Related Compound C) at the 12-month stability test station.
Recall numbers:	D-1333-2012
Losartan Potassium Tablets USP, 50 mg, 1000 film coated tablets, NDC 16714-582-03.
Code: Lot #G00921A EXP AUG 2013 Lot #G00922A EXP AUG 2013 Lot #G00923A EXP AUG 2013
Manufacturer:	Actavis Pharma Manufacturing Private Ltd., Kanchipuram, India
Recalled by:	Actavis Pharma Manufacturing Private Ltd. by letters dated Jan. 5, 2012. Firm-initiated recall is ongoing.
Distribution:	TN; 302 bottles
Reason:	Presence of foreign substance; magnesium stearate excipient used in the product was found to be contaminated with zeolite, calcium hydroxide, dibenzoylmethane and bisphenol A.
Recall numbers:	D-1334-2012
EDITORS’ NOTE: Tabulation prepared from information provided by FDA. The agency has three classes of recalls. Class I - violative product poses reasonable probability of serious adverse health consequences or death; Class II - violative product may cause temporary or medically reversible adverse health consequences; probability of serious consequences remote; Class III - violative product not likely to cause adverse health consequences.