Drug product
M.I.C 25/50/50 W/PRES. (BENZYL ETOH 2%) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50/MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
D-1224-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 500 mL in Vials
- Official record key
drug-enforcement:D-1224-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: a) Lot #: 160107-17, BUD: 07/05/16. b) Lot #: 160107-17, BUD: 07/05/16.
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility