🍔 Food 💊 Drugs 🏥 Medical Devices
PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold (dextromethorphan HBr 5 mg and Phenylephrine HCl 2.5 mg) and NIGHTTIME MULTI-SYMPTOM Cold (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL oz (118 mL) bottles, one each of DAYTIME MULTI-SYMPTOM Cold, Distributed by Medtech Products, Inc., Tarrytown, NY --- UPC 814832013523 Class III

Reason: Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution

Prestige Brands Holdings 20140425 Terminated
Distributed: Nationwide, and one consignee in Libya
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PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL OZ (118 mL), Distributed by Medtech Products, Inc., Tarrytown,NY ---- UPC 814832013544 Class III

Reason: Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution

Prestige Brands Holdings 20140425 Terminated
Distributed: Nationwide, and one consignee in Libya
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Burn 7 Capsules, supplied in 30 capsules bottle Class I

Reason: Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement

Deseo Rebajar 20131223 Terminated
Distributed: Puerto Rico only
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Cefpodoxime Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only. Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540. NDC 0781-5439-20. Class II

Reason: Presence of Foreign Substance: Presence of stainless steel particles.

Sandoz, Inc 20140522 Terminated
Distributed: Nationwide including Puerto Rico.
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Red Yeast Rice High Potency Dietary Supplement, 600 mg, packaged in a) 120-count VegeCaps per bottle (UPC 8 01650 02205 9) and b) 500-count VegeCaps per bottle (UPC 8 01650 02206 6), Manufactured by: Back to Health, Eugene, Oregon 97402. Class II

Reason: Marketed Without An Approved NDA/ANDA: Product is being recalled due to excessive levels of lovastatin. Lovastatin is an FDA approved drug making this dietary supplement an unapproved new drug.

Independent Nutrition Center, Inc. 20140429 Terminated
Distributed: Nationwide and Puerto Rico
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Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed from Mylan Laboratories Inc., Under license from Janssen Pharmaceutica NV, Belgium, Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, NDC 0456-1420-30 Class II

Reason: Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification throughout the product's shelf life.

Forest Pharmaceuticals Inc 20140512 Terminated
Distributed: Nationwide and Puerto Rico
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Oasis TEARS, Lubricant Eye Drops, 10mL/0.3 fl. oz. Bottle, OTC Only. Distributed by: OASIS, OASIS Medical, Inc., Glendora, CA 91741. UPC: 8 54819 00002 3. Class III

Reason: Labeling: Missing Label; The label on the immediate bottle is missing.

Oasis Medical Inc 20140514 Terminated
Distributed: Nationwide in US
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NATURECT Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10, 20, and 40- count bottles, Distributed by P-Boost, Los Angeles, CA 900466 Class I

Reason: Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.

Tendex 20131119 Terminated
Distributed: Nationwide.
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P-BOOST Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10, 20, and 40- count bottles, Distributed by P-Boost, Los Angeles, CA 900466 Class I

Reason: Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.

Tendex 20131119 Terminated
Distributed: Nationwide.
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Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-018-02 and b) 1000-count bottle NDC 42794-018-06, SigmaPharm Laboratories, LLC, Bensalem, Pa. Class II

Reason: Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product.

SigmaPharm Laboratories LLC 20140422 Terminated
Distributed: Nationwide and Puerto Rico
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