Drug product
LIPO-BOOST W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-52MG, METHYL, B12-500MCG, CARNITINE 50 MG, METHIONINE 12.5MG, INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE 30MG/ML, In a) 3ML Vials and b) 5ML Vials, MEDAUS PHARMACY
D-1205-2016
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 74466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 65 mL in Vials
- Official record key
drug-enforcement:D-1205-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: a) Lot #: 160209-36, BUD: 07/31/16. b) Lot #: 151202-20, BUD: 05/26/16; Lot #: 151214-49, BUD: 05/26/16.
Distribution pattern: U.S. Nationwide, Japan, and New Zealand.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility