Recalls / Class II

Class IID-1171-2016

Product

B-COMPLEX WITHOUT B12 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY

Affected lot / code info

a) Lot #: 151222-11, BUD: 05/28/16; Lot #: 151224-5, BUD: 05/28/16; Lot #: 160111-1, BUD: 05/28/16; Lot #: 160119-3, BUD: 05/28/16; Lot #: 160119-64, BUD: 05/28/16; Lot #: 160217-10, BUD: 05/28/16; Lot #: 160307-22, BUD: 05/28/16. b) Lot #: 151223-30, BUD: 05/28/16; Lot #: 151224-2, BUD: 05/28/16; Lot #: 160111-1, BUD: 05/28/16; Lot #: 160112-2, BUD: 05/28/16; Lot #: 160118-2, BUD: 05/28/16; Lot #: 160119-64, BUD: 05/28/16; Lot #: 160125-1, BUD: 05/28/16; Lot #: 160208-4, BUD: 05/28/16; Lot #: 160210-64, BUD: 05/28/16; Lot #: 160215-6, BUD: 05/28/16; Lot #: 160222-14, BUD: 05/28/16; Lot #: 160307-22, BUD: 05/28/16; Lot #: 160307-23, BUD: 06/11/16.

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

955 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-1171-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.