Class I - Dangerous
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
Class I - Dangerous
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01.
Lupin Pharmaceuticals
Class I - Dangerous
Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI 49010, 45802-401-09
Perrigo New York
Class I - Dangerous
Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
Class I - Dangerous
Failed dissolution specifications
Class I - Dangerous
Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
Class I - Dangerous
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India NDC 55111-533-01
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Dissolution Specifications: Out of specification results observed for high dissolution.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class I - Dangerous
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class I - Dangerous
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class I - Dangerous
Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
Class I - Dangerous
Labeling: Incorrect expiration date.
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: Consumer complaint and subsequent testing found lot to be out of specification for mold.
Class I - Dangerous
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Class I - Dangerous
Failed Stability Specification: out of specification results for Sodium Perborate
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.