Recalls / Class II
Class IID-1219-2016
Product
METHYL B12 10MG/ML W/PRES (BENZALKONIUM 0.01%) IN NACL 0.9%, In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY
- Affected lot / code info
- a) Lot #: 160201-11, BUD: 07/11/16; Lot #: 160215-13, BUD: 07/11/16; Lot #: 160309-4, BUD: 07/11/16. b) Lot #: 160315-1, BUD: 07/11/16; Lot #: 160201-11, BUD: 07/11/16; Lot #: 160210-71, BUD: 07/11/16; Lot #: 160309-4, BUD: 07/11/16. c) Lot #: 160125-17, BUD: 07/11/16; Lot #: 160210-35, BUD: 07/11/16; Lot #: 160222-20, BUD: 07/11/16; Lot #: 160204-46, BUD: 07/11/16; Lot #: 160307-25, BUD: 07/11/16.
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
- 331 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-1219-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.