Recalls / Class II
Class IID-1175-2016
Product
B-COMPLEX W/METHYL B12/LIDO W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, LIDOCAINE 1%, METHYL B12 1MG/ML, In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY
- Affected lot / code info
- a) Lot #: 151228-62, BUD: 06/25/16. b) Lot #: 160111-2, BUD: 06/11/16; Lot #: 160113-3, BUD: 06/11/16; Lot #: 160113-76, BUD: 06/11/16; Lot #: 160118-1, BUD: 06/11/16; Lot #: 160119-2, BUD: 06/11/16; Lot #: 160119-65, BUD: 06/11/16; Lot #: 160122-9, BUD: 06/11/16; Lot #: 160128-10, BUD: 06/11/16; Lot #: 160202-65, BUD: 06/11/16; Lot #: 160204-44, BUD: 06/11/16; Lot #: 160217-54, BUD: 06/11/16; Lot #: 160223-5, BUD: 06/11/16; Lot #: 160224-66, BUD: 06/11/16; Lot #: 160229-23, BUD: 06/11/16; Lot #: 160315-3, BUD: 06/11/16. c) Lot #: 160118-1, BUD: 06/11/16; Lot #: 160127-2, BUD: 06/11/16; Lot #: 160210-37, BUD: 06/11/16; Lot #: 160223-5, BUD: 06/11/16; Lot #: 160310-14, 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
- 370 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-1175-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.