💊 Drugs • 11,927 recalls
Spectrum Laboratory Products
CGMP Deviations: Presence of NDMA impurity detected in product.
Teva Pharmaceuticals USA
GMP Deviations: Product bottle may be absent of desiccant.
Graviti Pharmaceuticals Private Limited
Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg.
CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Failed Dissolution Specifications: low out of specification results for dissolution testing.
Teva Pharmaceuticals USA
GMP Deviations: Product bottle may be absent of desiccant.
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Pharmaceutical Associates
Subpotent: Out of specification for assay at the 12-month time point.
MPRX, Inc.
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
MPRX, Inc.
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
MPRX, Inc.
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
MPRX, Inc.
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
McGuff Compounding Pharmacy Services
Presence of Particulate Matter: Particulates observed in vials release for dispensing.
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
MPRX, Inc.
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
MPRX, Inc.
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Tuscano and Delucia Group (DBA Entropic Labs)
Marketed Without An Approved NDA/ANDA: product contains Selective Androgen Receptor Modulators (SARMs)
Mylan Pharmaceuticals
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.