Recalls / Class II
Class IID-1228-2016
Product
NA ASCORBATE 500MG/ML (PF), In a) 10ML Vials, b) 50ML Vials, and c) 100ML Vials, MEDAUS PHARMACY
- Affected lot / code info
- a) Lot #: 151217-47, BUD: 06/14/16; Lot #: 160112-51, BUD: 07/10/16; Lot #: 160127-43, BUD: 07/25/16; Lot #: 160218-8, BUD: 08/16/16; Lot #: 151211-26, BUD: 06/08/16. b) Lot #: 151211-26, BUD: 06/08/16; Lot #: 151217-47, BUD: 06/14/16; Lot #: 160112-51, BUD: 07/10/16; Lot #: 160127-43, BUD: 07/25/16; Lot #: 160218-8, BUD: 08/16/16. c) Lot #: 151211-26, BUD: 06/08/16; Lot #: 160112-51, BUD: 07/10/16; Lot #: 160127-43, BUD: 07/25/16; Lot #: 151217-47, BUD: 06/14/16; Lot #: 160218-8, BUD: 08/16/16.
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
- 157,500 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-1228-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.