💊 Drugs • 11,927 recalls
Calvin Scott & Company
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
PAI Holdings, LLC.
Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent.
CGMP Deviations: Presence of NDMA impurity detected in product.
Failed Stability Specifications: Below specification result for buprenorphine release rate.
Arbor Pharmaceuticals
Subpotent Drug
CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
Legacy Pharmaceutical Packaging
Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
Failed Dissolution Specifications
CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
CGMP Deviations
Preferred Pharmaceuticals
CGMP Deviations
Preferred Pharmaceuticals
CGMP Deviations
The Protein Shoppe
Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug fro which the safety and efficacy have not been established and therefore subject to recall.
Preferred Pharmaceuticals
CGMP Deviations
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.