FDA Drug Recalls

Recalls / Class II

Class IID-1169-2016

Product

B-COMPLEX (LIEBERMAN) IN NACL 0.9% (PF), B1-12.5MG, B2-5-PO4-10MG, B3-12.5MG, B5-12.5MG, B6-12.5MG/ML, 2ML Vials, MEDAUS PHARMACY

Affected lot / code info
Lot #: 151229-15, BUD: 06/26/16

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm
Medaus, Inc.
Notification channel
E-Mail
Type
Voluntary: Firm initiated
Address
6801 Cahaba Valley Rd Ste 116, Birmingham, Alabama 35242-9609

Distribution

Quantity
60 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-1169-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls