Class I - Dangerous
Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg capsules contained a single peach colored capsule printed TKN250 which was identified as a Tikosyn (dofetilide) capsule.
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Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5379-56, UPC 3 0093-5379-56 2.
Teva Pharmaceuticals USA
Class I - Dangerous
Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
Class I - Dangerous
Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Class I - Dangerous
Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5378-56, UPC 3 0093-5378-56 5.
Teva Pharmaceuticals USA
Class I - Dangerous
Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule, Distributed by: Power Life Distributors, COK Inc., Los Angeles, CA.
Schindele Enterprises
Class I - Dangerous
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
Class I - Dangerous
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection.
Class I - Dangerous
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims.
Class I - Dangerous
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Class I - Dangerous
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.
REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. Previene el cancer en los huesos, Nueva presentacion el original.
Pain Free By Nature
Class I - Dangerous
Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol.
Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling indicates it is to be used for the treatment of disease.
PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Konsyl Pharmaceuticals, Inc., Easton, MD 21601. NDC: 0224-1847-10.
Konsyl Pharmaceuticals
Class I - Dangerous
Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate.
Class I - Dangerous
Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.
Class I - Dangerous
This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.