D-1223-2016 Class II Terminated
FDA drug recall D-1223-2016 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: 1430 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
- 1430 mL in Vials
Product Description
M.I.C B-COMPLEX W/PRES. (BENZYL ETOH 2%) B1-50MG;B2-5-PO4-5MG;B3-50MG;B5-5MG;B6-5MG; CYANO B12 100MCG; CHOLINE CHL-50MG; INOSITOL-25MG;METHIONINE 12.5MG/ML, 5ML Vials, MEDAUS PHARMACY
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S. Nationwide, Japan, and New Zealand.
Code Information
Lot #: 160119-59; BUD: 05/26/16, Lot #: 151228-72; BUD: 05/26/16, Lot #: 160127-4; BUD: 05/26/16, Lot #: 160201-13; BUD: 05/26/16, Lot #: 160202-13; BUD: 05/26/16, Lot #: 160204-11; BUD: 05/26/16, Lot #: 160202-66; BUD: 06/11/16, Lot #: 160307-31; BUD: 06/11/16, Lot #: 160224-68; BUD: 06/11/16, Lot #: 160205-8; BUD: 06/11/16