Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Prescription Drugs
💊 Drugs • 12,141 recalls
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
DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking.
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
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Out-of-specification organic impurity results obtained during routine stability testing.
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
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
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
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
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
CGMP Deviations: Presence of NDMA impurity detected in product.
Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
Diethylpropion, 75 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1477-01
Calvin Scott & Company
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical Associates, Inc. Greenville, SC 29605 NDC 0121-1696-40
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.
Nymalize (nimodipine) oral solution, 60 mg/20 mL, 12 Unit-Dose Cups and 12 Oral Syringes, 2 inner cartons per outer shipping carton, Rx Only, Distributed by arbor Atlanta, GA, NDC 24338-200-12
Arbor Pharmaceuticals
Subpotent Drug