Drug product
LIPO B CYANO 1MG/ML W/PRES. (BENZYL ETOH 1%) METHIONINE 25MG, INOSITOL 50MG, CHOLINE CHL-50MG, CYANO B-12-100MCG, BENZYL ALCOHOL 1%/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
D-1204-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 155 mL in Vials
- Official record key
drug-enforcement:D-1204-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: a) Lot #: 151203-50, BUD: 05/26/16; Lot #: 160128-34, BUD: 07/26/16; Lot #: 160229-51, BUD: 07/31/16. b) Lot #: 151204-10, BUD: 05/26/16; Lot #: 151204-19, BUD: 05/26/16.
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility