Class I - Dangerous
Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
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Prescription Drugs
💊 Drugs • 11,927 recalls
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
Class I - Dangerous
Presence of particulate matter in solution - black and transparent particles
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01
Nostrum Laboratories
Class I - Dangerous
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 tablets NDC: 43063-902-30; b) 60 tablets NDC: 43063-902-60
PD-Rx Pharmaceuticals
Class I - Dangerous
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01
Nostrum Laboratories
Class I - Dangerous
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubilant Generics, Ltd., Roorkee, India, Marketed by: Jubilant Cardista Pharmaceuticals, Inc., Salisbury, MD NDC 59746-0306-32
Jubilant Cadista Pharmaceuticals
Class I - Dangerous
Subpotent
Class I - Dangerous
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class I - Dangerous
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class I - Dangerous
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class I - Dangerous
Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
Class I - Dangerous
Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
Class I - Dangerous
Failed Dissolution Specification
Class I - Dangerous
Failed Dissolution Specification
Class I - Dangerous
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class I - Dangerous
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0006-01
Boehringer Ingelheim Pharmaceuticals
Class I - Dangerous
An extraneous peak was observed for dissolution testing.
N-A-C (N-Acetyl-L-Cysteine, 500 mg, 100 capsules; Veggie Caps, white HDPE bottle with RED label Product # 107002 UPC: 790011070023
Jarrow Formulas
Class I - Dangerous
Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap.