Drug product
L-PHENYLALANINE 15MG/ML (PF), 50ML Vials, MEDAUS PHARMACY
D-1199-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 55 mL in Vials
- Official record key
drug-enforcement:D-1199-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 160308-2, BUD: 09/04/16
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility