💊 Drugs • 12,141 recalls
SCA Pharmaceuticals
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.
SCA Pharmaceuticals
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Fresenius Kabi USA
Presence of Particulate Matter - found in reserve sample vials at the firm.
Failed Impurity/Degradation Specifications
Failed Moisture Limits
Failed Impurity/Degradation Specifications
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
CGMP Deviations
SCA Pharmaceuticals
Subpotent drug.
Morton Grove Pharmaceuticals
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.