Drug product
LIPO-INJECTION W/METHYL B12 500 MCG/ML W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-500MCG, LIDOCAINE-10MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
D-1207-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4000 mL in Vials
- Official record key
drug-enforcement:D-1207-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: a) Lot #: 151210-40, BUD: 05/26/16; Lot #: 160229-60, BUD: 07/31/16. b) Lot #: 151210-40, BUD: 05/26/16; Lot #: 160229-60, BUD: 07/31/16.
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility