Class II · Moderate risk
8.4% Sodium Bicarbonate Injection
Lack of Assurance of Sterility
FDA Drug Recalls
1,018 recalls, newest first
Class II · Moderate risk
Tretinoin Capsules
Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
Class III · Low risk
Mucus Relief D
Subpotent drug
Class II · Moderate risk
Clobetasol Propionate Foam
CGMP Deviations
Class III · Low risk
Class III · Low risk
Class II · Moderate risk
Clobazam Oral Suspension 2.5 mg/mL
Failed Stability Specifications
Class I · High risk
Semglee (insulin glargine)
Labeling: Missing Label: label missing from some Semglee prefilled pens.
Class II · Moderate risk
Sufentanil Citrate Injection
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Class III · Low risk
Leader
Failed Dissolution Specifications
Class III · Low risk
CVS Health
Failed Dissolution Specifications
Class III · Low risk
Qc Quality Choice
Failed Dissolution Specifications
Class III · Low risk
equate
Failed Dissolution Specifications
Class III · Low risk
Dr. Reddys
Failed Dissolution Specifications
Class III · Low risk
Kroger
Failed Dissolution Specifications
Class III · Low risk
Rite Aid Pharmacy
Failed Dissolution Specifications
Class III · Low risk
Rugby
Failed Dissolution Specifications
Class III · Low risk
Wal-Fex D
Failed Dissolution Specifications