Drug product
L-CARNITINE 250MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
D-1196-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2250 mL in Vials
- Official record key
drug-enforcement:D-1196-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 151123-72, BUD: 05/21/16; Lot #: 151124-33, BUD: 05/22/16; Lot #: 151217-18, BUD: 06/14/16; Lot #: 151217-22, BUD: 06/14/16; Lot #: 151221-3, BUD: 06/18/16; Lot #: 160303-64, BUD: 08/30/16
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility