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Showing 16,181–16,200 of 17,987 drug recalls
Drug RecallTerminatedHistorical recordClass I
72HP MAXIMUM POTENCY MALE SEXUAL ENHANCEMENT, Dietary Supplement, supplied in 1 capsule per blister pack, Distributed by: 72HP, Inc. Weston, FL
by Fabscout Entertainment, Inc
Reason
Marketed without an Approved NDA/ANDA: products were found to contain undeclared sildenafil
Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ (30 mL) bottle, sold under the following labels: (a) CVS pharmacy brand LUBRICANT EYE DROPS FOR MILD TO MODERATE DRY EYE, Distributed by CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 053357 7 and UPC 0 50428 27364 7; (b) equate brand Lubricant Eye Drops, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, UPC 6 81131 03420 3; and (c) up & up brand lubricant eye drops, Dist. by Target Corporation, Minneapolis, MN 55403, UPC 8 58961 79102 0.
by Altaire Pharmaceuticals, Inc.
Reason
Non-Sterility: Customer complaints of mold in the product after use and handling due to the fact that the preservative used in the lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution may not be effective through expiry.
Multi-Mineral capsules, 200-count bottles, labeled in part as Healthy Life Chemistry, By Purity First, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735; 1-800-696-7017
by Healthy Life Chemistry Inc dba Purity First
Reason
Marketed Without An Approved NDA/ANDA: New York State Department of Health analysis of this product found it to contain undeclared steroid-like substances making it an unapproved new drug.
Recall initiated
July 31, 2013
Reported by FDA
December 25, 2013
Distribution
Approximately 30% of all finished products were sold to customers in interstate to include but may not be limited to NY, NJ & CT via UPS. Products are promoted and sold directly to customers at Healthy Life Chemistry's retail store at 13A Lucon Drive in Deer Park, NY, on the company website (www.purityfirst.com), and are available at the health food store, Total Health, located at 120 Rte 110, Farmingdale, NY (www.totaldiscountvitamins.com).
B-50 capsules, 100-count bottles, labeled in part as Healthy Life Chemistry, By Purity First, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735; 1-800-696-7017
by Healthy Life Chemistry Inc dba Purity First
Reason
Marketed Without An Approved NDA/ANDA: FDA analysis of this product found it to contain undeclared steroids and steroid-like substances making this an unapproved new drug.
Recall initiated
July 31, 2013
Reported by FDA
December 25, 2013
Distribution
Approximately 30% of all finished products were sold to customers in interstate to include but may not be limited to NY, NJ & CT via UPS. Products are promoted and sold directly to customers at Healthy Life Chemistry's retail store at 13A Lucon Drive in Deer Park, NY, on the company website (www.purityfirst.com), and are available at the health food store, Total Health, located at 120 Rte 110, Farmingdale, NY (www.totaldiscountvitamins.com).
Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-di-Desmethylsibutramine, and trace amounts of sibutramine and N-Desmethylsibutramine. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.
Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine, N-Desmethylsibutramine and phenolphthalein. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.
Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 7 9357304140 1
by Zi Xiu Tang Success, LLC
Reason
Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss but removed from the market for safety reasons, making these products unapproved new drugs.
Recall initiated
October 22, 2012
Reported by FDA
December 25, 2013
Distribution
Nationwide and Canada to distributors and consumers.
Classic Zi Xiu Tang, Bee Pollen Capsule, Net Wt. 250 mg x 60 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 6 937000 700019
by Zi Xiu Tang Success, LLC
Reason
Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss but removed from the market for safety reasons, making these products unapproved new drugs.
Recall initiated
October 22, 2012
Reported by FDA
December 25, 2013
Distribution
Nationwide and Canada to distributors and consumers.
Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Mfd by: Shasun Chemicals and Drugs Limited, Unit II, R. S. Na 32, 33, 743 PIMS Rd, Periyakalepet, Pondicherry. 605014 INDIA. NDC 0143-9749-10.
by West-Ward Pharmaceutical Corp.
Reason
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing
Carbon Dioxide, USP, Medical Gas, Rx only, Non Flammable Gas 2, in 50 lbs steel cylinders, Distributed by AIRGAS USA, LLC Radnor, PA
by Airgas Medical Services
Reason
Labeling: Not Elsewhere Classified; Due to an error in the manufacturing procedure, a cylinder in liquid withdrawal service was not marked Syphon Tube indicating liquid withdrawal and shipped as a gas withdrawal cylinder.
I MUSTACHE YOU TO BE MY BFF Justice, COTTON CANDY scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
by Tween Brands Inc
Reason
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
