Drug product
PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-604-01
D-1545-2014
Product summary
- Event
- Event 68910
- Status
- Terminated
- Classification
- Class II
- Quantity
- 56,060 vials
- Official record key
drug-enforcement:D-1545-2014
Official wording
Reason: CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection.
Code information: Lot 6007698, Exp. 03/16
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations