💊 Drugs • 12,141 recalls
PD-Rx Pharmaceuticals
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Nostrum Laboratories
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Jubilant Cadista Pharmaceuticals
Subpotent
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
Failed Dissolution Specification
Failed Dissolution Specification
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Boehringer Ingelheim Pharmaceuticals
An extraneous peak was observed for dissolution testing.
Jarrow Formulas
Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap.
SUBPOTENT DRUG
Boehringer Ingelheim Pharmaceuticals
An extraneous peak was observed for dissolution testing.
Boehringer Ingelheim Pharmaceuticals
An extraneous peak was observed for dissolution testing.
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Acella Pharmaceuticals
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.