Class I - Dangerous
SUBPOTENT DRUG
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Prescription Drugs
💊 Drugs • 11,927 recalls
Catapres (clonidine hydrochloride, USP) 0.2 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0007-01
Boehringer Ingelheim Pharmaceuticals
Class I - Dangerous
An extraneous peak was observed for dissolution testing.
Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0011-01
Boehringer Ingelheim Pharmaceuticals
Class I - Dangerous
An extraneous peak was observed for dissolution testing.
Class I - Dangerous
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-327-01
Acella Pharmaceuticals
Class I - Dangerous
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Class I - Dangerous
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Class I - Dangerous
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Class I - Dangerous
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Desflurane, USP Liquid for Inhalation, 240 mL, Rx Only, Manufactured by: Shanghai Hengrui Pharmaceutical Co., Ltd., Shanghai, 200245, China for Sandoz Inc. Princeton, NJ 08540, NDC 0781-6172-22
eVenus Pharmaceutical Laboratories
Class I - Dangerous
DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking.
Class I - Dangerous
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-328-01
Acella Pharmaceuticals
Class I - Dangerous
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Class I - Dangerous
Out-of-specification organic impurity results obtained during routine stability testing.
Class I - Dangerous
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Class I - Dangerous
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Class I - Dangerous
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Diethylpropion, 25 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1475-01
Calvin Scott & Company
Class I - Dangerous
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer
Phentermine, 30 mg capsules, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-0597-10
Calvin Scott & Company
Class I - Dangerous
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot