💊 Drugs • 11,927 recalls
Crown Laboratories
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Aurobindo Pharma USA
Failed Impurities/ Degradation Specifications
SCA Pharmaceuticals
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Hikma Pharmaceuticals USA
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
Aurobindo Pharma USA
Failed Impurities/ Degradation Specifications
Hikma Pharmaceuticals USA
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Presence of Particulate Matter - found in reserve sample vials at the firm.
Discoloration: Out of Specification (OOS) result for APHA Color Test.
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
Subpotent drug - Product did not contain drug.
Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.
Presence of Particulate Matter - found in reserve sample vials at the firm.
Presence of Particulate Matter: particulate matter identified after reconstitution.
American Health Packaging
Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
Some bottles may contain mixed strengths of the product.
Acella Pharmaceuticals
Superpotent Drug.