D-1208-2016 Class II Terminated
FDA drug recall D-1208-2016 was initiated by Medaus, Inc. on May 13, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated June 16, 2017). Affected quantity: 7000 mL in Vials.
Recall Details
- Product Type
- Drugs
- Report Date
- July 20, 2016
- Initiation Date
- May 13, 2016
- Termination Date
- June 16, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7000 mL in Vials
Product Description
LIPO-INJECTION W/METHYL B12 500 MCG/CARNITINE/NO VIT C W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-500MCG, LIDOCAINE-10MG, CARNITINE 25MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S. Nationwide, Japan, and New Zealand.
Code Information
a) Lot #: 151228-58, BUD: 05/26/16; Lot #: 160203-6, BUD: 07/31/16. b) Lot #: 151228-58, BUD: 05/26/16; Lot #: 160203-6, BUD: 07/31/16.