FDA Recalls For Dec. 11 And 18, 2013

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

DRUGS – CLASS II
1) Badger Kids Broad Spectrum SPF30 Zinc Oxide Sunscreen Lotion Tangerine & Vanilla, 4 fl. oz., tube; 2) Badger Baby Broad Spectrum SPF 30 Zinc Oxide Sunscreen Lotion Chamomile & Calendula, 4 fl. oz., tube.
Code: 1) Lot #: 3164A, Exp 06/15, UPC 634084490145 (U.S.), 634084490169 (Canada); 2) Lot # 3024A EXP 01/15; 3057A EXP 02/15; 3063A EXP 03/15; 3063B EXP 03/15; 3132A; 3133A EXP 05/15, UPC 634084490091 (U.S.), 634084490114 (Canada).
Manufacturer:	W.S. Badger Company Inc., Gilsum, NH
Recalled by:	Badger by letter on Sept. 24, 2013.
Distribution:	Nationwide U.S. and Canada, Greece, Singapore, Thailand, Norway, American Samoa; 1) 36,272 tubes, 2) 5,941 tubes.
Reason:	Microbial contamination of non-sterile products; selected lots were recalled due to microbial contamination.
Recall numbers:	D-324-2014, D-325-2014
FOOD – CLASS II
1) HCG Premium, Hormone-Free Drops 60 ml; 2) Moringa Premium 60 capsules; 3) HCG Premium Cleanse Hormone-Free Drops with Acai Berry & Raspberry Ketone, 60 ml; 4) HCG Premium Energy Hormone-Free Drops with B12, B6 & Yohimbine, 60 ml.
Code: No information.
Manufacturer:	Borinquen Natural, Carolina, PR
Recalled by:	Borinquen Natural by visit on Sept. 9, 2013.
Distribution:	Puetro Rico; 1,418, total for all varieties.
Reason:	Distributed dietary supplements with the following claims: "drops the fat, expels toxins, break down fat, block carbohydrates, suppresses appetite, suppresses fat absorption, creates a balance in the thyroid.” In addition, the firm's website claimed to repair body tissue, such as minor ulcers and to contain anti-cancer compounds.
Recall numbers:	F-0691-2014, F-0692-2014, F-0693-2014, F-0694-2014
Allergy Research Group Sugar Balance Formula, dietary supplement, Hypoallergenic, 90 vegetarian capsules; formulated exclusively for Allergy Research Group.
Code: product # 75660, lot # 0613057; expiration: August 2015.
Manufacturer:	N/A
Recalled by:	Allergy Research Group, Alameda, CA, by letter on Nov. 11, 2013.
Distribution:	IL, FL. GA, NV, NY, CA, NH, AZ and Switzerland and New Zealand; 182 bottles of 90 capsules each.
Reason:	Firm was notified by its contract manufacturer that a voluntary recall had been issued by the raw material supplier because certain cellulase enzymes have been found to be contaminated with chloramphenicol.
Recall numbers:	F-703-2014
DRUGS – CLASS II
1) Badger Kids Broad Spectrum SPF30 Zinc Oxide Sunscreen Lotion Tangerine & Vanilla, 4 fl. oz., tube; 2) Badger Baby Broad Spectrum SPF 30 Zinc Oxide Sunscreen Lotion Chamomile & Calendula, 4 fl. oz., tube.
Code: 1) Lot #: 3164A, Exp 06/15, UPC 634084490145 (U.S.), 634084490169 (Canada); 2) Lot # 3024A EXP 01/15; 3057A EXP 02/15; 3063A EXP 03/15; 3063B EXP 03/15; 3132A; 3133A EXP 05/15, UPC 634084490091 (U.S.), 634084490114 (Canada).
Manufacturer:	W.S. Badger Company Inc., Gilsum, NH
Recalled by:	Badger by letter on Sept. 24, 2013.
Distribution:	Nationwide U.S. and Canada, Greece, Singapore, Thailand, Norway, American Samoa; 1) 36,272 tubes, 2) 5,941 tubes.
Reason:	Microbial contamination of non-sterile products; selected lots were recalled due to microbial contamination.
Recall numbers:	D-324-2014, D-325-2014
FOOD – CLASS II
1) HCG Premium, Hormone-Free Drops 60 ml; 2) Moringa Premium 60 capsules; 3) HCG Premium Cleanse Hormone-Free Drops with Acai Berry & Raspberry Ketone, 60 ml; 4) HCG Premium Energy Hormone-Free Drops with B12, B6 & Yohimbine, 60 ml.
Code: No information.
Manufacturer:	Borinquen Natural, Carolina, PR
Recalled by:	Borinquen Natural by visit on Sept. 9, 2013.
Distribution:	Puerro Rico; 1,418, total for all varieties.
Reason:	Distributed dietary supplements with the following claims: "drops the fat, expels toxins, break down fat, block carbohydrates, suppresses appetite, suppresses fat absorption, creates a balance in the thyroid.” In addition, the firm's website claimed to repair body tissue, such as minor ulcers and to contain anti-cancer compounds.
Recall numbers:	F-0691-2014, F-0692-2014, F-0693-2014, F-0694-2014
Allergy Research Group Sugar Balance Formula, dietary supplement, Hypoallergenic, 90 vegetarian capsules; formulated exclusively for Allergy Research Group.
Code: product # 75660, lot # 0613057; expiration: August 2015.
Manufacturer:	Allergy Research Group, Alameda, CA
Recalled by:	Allergy Research by letter on Nov. 11, 2013.
Distribution:	IL, FL. GA, NV, NY, CA, NH, AZ and Switzerland and New Zealand; 182 bottles of 90 capsules each.
Reason:	Firm was notified by their contract manufacturer that a voluntary recall had been issued by the raw material supplier because certain cellulase enzymes have been found to be contaminated with chloramphenicol.
Recall numbers:	F-703-2014
Dec. 18: DRUGS – CLASS I
1) Volcano Male Enhancement Liquid, 2 FL OZ (60 ml) bottle; 2) Volcano Male Enhancement (proprietary formula, pueraria lobata, cinnamon mark, cuscuta, gui, licorice, altractylodes, dang condonopsis, dismutase, cornus, rubus, deng sen extract, panax ginseng, cordyceps sinensis, go ji extract, superoxide dismutase) capsules,1,500 mg, 1-count capsule packaged in a black round plastic pop top container.
Code: 1) All lots including 0312-K2, Exp 11/14; 2) No codes or lots listed on products.
Manufacturer:	Myson Corp. Inc., Long Beach, CA
Recalled by:	Myson by letter on July 19, 2013.
Distribution:	Nationwide U.S.; 1) 70 bottles, 2) unknown.
Reason:	Marketed without an approved NDA/ANDA: all lots of Volcano Liquid and Volcano Capsules, marketed as dietary supplements, are being recalled because they were found to contain undeclared active pharmaceutical ingredients, making them unapproved new drugs.
Recall numbers:	D-344-2014, D-345-2014
FOOD – CLASS II
1) a) Vitacost Mega Spectrum Enzyme, packaged with 180 vegetarian capsules and b) Vitacost Super Daily Enzymes 500 mg caps, product is packaged in a plastic bottle with 240 capsules per bottle (both manufactured for Vitacost Lexington, NC); 2) 27295 Digestive Enzyme Complex/Enzyme Formula Caps, Quantity:13M, Product #: IB286, product is packaged in bulk form, manufactured for Indiana Botanic, manufactured by Nature's Value Inc.
Code: 1) a) lot # 131623, exp. date 05/15, Item # VCT7015191, UPC 84419701519, b) lot # 132176, exp. date 06/15, Item # VCT 7017164, and lot #132843, exp. date 07/15, Item #: VCT7017164. UPC 844197017164; 2) lot # 132337.
Manufacturer:	Nature's Value Inc., Coram, NY.
Recalled by:	Nature’s Value by letter on Oct. 17, 2013.
Distribution:	FL & IN; 796,800 total capsules for all varieties.
Reason:	Due to the presence of chloramphenicol, an antimicrobial agent.
Recall numbers:	F-0824-2014, F-0826-2014, F-0825-2014
Dietary supplements and ingredients marketed by businesses that are customers of Natural Enzyme Co., Forsyth, MO. (Additional information on the products included in the 80 separate recall files that FDA included in this report is available in “The Tan Sheet” online.)
Manufacturer:	National Enzyme Co., Forsyth, MO
Recalled by:	National Enzyme Co. by email, fax, letter, press release, telephone or visit on Oct. 30, 2013.
Distribution:	Domestic distribution nationwide with direct accounts in 27 states in all regions. Foreign distribution through direct accounts in Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the U.K.
Reason:	National Enzyme Co. is recalling dietary supplements and ingredients marketed by its customers because the ingredient the firm provided contains a raw material which may contain more than 0.3 ppb chloramphenicol.
Recall numbers:	F-0734-2014 through F-0814-2014
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.