Drug product
M.I.C. 25/50/50 (PF) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50MG/ML, In 2ML Vials, MEDAUS PHARMACY
D-1220-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 187 mL in Vials
- Official record key
drug-enforcement:D-1220-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 151130-48, BUD: 05/26/16; Lot #: 151215-7, BUD: 05/26/16; Lot #: 151216-12, BUD: 05/26/16; Lot #: 160106-27, BUD: 05/26/16; Lot #: 160113-38, BUD: 07/11/16; Lot #: 160223-33, BUD: 07/31/16; Lot #: 160307-36, BUD: 07/31/16; Lot #: 160307-52, BUD: 07/31/16; Lot #: 160308-5, BUD: 07/31/16
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility