Drug product
Artesunate Lyophilized Powder for Injection, 60 mg per vial, Rx only, Manufactured by Park Compounding, Irvine, CA
D-1340-2015
Product summary
- Event
- Event 71078
- Status
- Terminated
- Classification
- Class II
- Quantity
- 172 vials ( 100 prescriptions)
- Official record key
drug-enforcement:D-1340-2015
Official wording
Reason: Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Code information: Lot # 12032014@2B; Exp.06/15 Lot # 12072014@3B; Exp.06/15 Lot # 01032015@2B; Exp.07/15 Lot # 02152015@2B; Exp.08/15
Distribution pattern: Nationwide.
Derived failure modes
-
Unknown
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.