Recalls / Class II
Class IID-1223-2016
Product
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
- Affected lot / code info
- 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
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Medaus, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 6801 Cahaba Valley Rd Ste 116, Birmingham, Alabama 35242-9609
Distribution
- Quantity
- 1430 mL in Vials
- Distribution pattern
- U.S. Nationwide, Japan, and New Zealand.
Timeline
- Recall initiated
- 2016-05-13
- FDA classified
- 2016-07-08
- Posted by FDA
- 2016-07-20
- Terminated
- 2017-06-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1223-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.