Drug product
Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceuticals, NDC 60793-0701-10
D-0373-2024
Product summary
- Event
- Event 93935
- Status
- Terminated
- Classification
- Class II
- Quantity
- 70 vials
- Official record key
drug-enforcement:D-0373-2024
Official wording
Reason: cGMP Deviations: Products were stored outside the drug label specifications.
Code information: 567951
Distribution pattern: Product was distributed to three direct accounts in NM, AZ and UT.
Derived failure modes
-
Manufacturing or process control
cGMP Deviations