Class I - Dangerous
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class I - Dangerous
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class I - Dangerous
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class I - Dangerous
CGMP Deviations: Out of specification for dissolution
Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN, 38141, Mfd. in India, NDC 16714-165-01.
Zydus Pharmaceuticals (USA)
Class I - Dangerous
Presence of particulate matter: glass
Class I - Dangerous
CGMP Deviations
STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473 ml), Distributed by: StellaLife, 2875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-143-16
Homeocare Laboratories
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
CGMP Deviations
STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 22875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-121-01
Homeocare Laboratories
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430,
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
Failed Dissolution Specifications: results below specifications
Class I - Dangerous
Cross contamination with other products.