Drug product
LIPO W/LIDOCAINE #3 W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID 50MG; B1-50MG;B2-5-P04-5MG;D3-30MG; B5-5MG;B6-5MG;CYANO B12-1MG; METHIONINE 12.5MG; INOSITOL-25MG; CHOLINE CL-25 MG; LIDOCAINE 10MG/ML, In a) 5 ML Vials and b) 10ML Vials, MEDAUS PHARMACY
D-1201-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7000 mL in Vials
- Official record key
drug-enforcement:D-1201-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: a) Lot #: 160107-37, BUD: 07/5/16; Lot #: 160303-67, BUD: 07/31/16. b) Lot #: 160107-37, BUD: 07/5/16; Lot #: 160303-67, BUD: 07/31/16.
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility