Drug product
MAGNESIUM CHL 200MG/ML (PF), In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
D-1211-216
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5000 mL in Vials
- Official record key
drug-enforcement:D-1211-216
Official wording
Reason: Lack of Assurance of Sterility
Code information: a) Lot #: 160203-19, BUD: 08/01/16; Lot #: 160222-60, BUD: 08/20/16. b) Lot #: 160203-19, BUD: 08/01/16; Lot #: 160222-60, BUD: 08/20/16.
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility