Recalls / Class II
Class IID-1181-2016
Product
DMSO 99.9 (PF), In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
- Affected lot / code info
- a) Lot #: 151217-2, BUD: 05/30/16; Lot #: 160115-6, BUD: 05/30/16; Lot #: 160303-8, BUD: 08/30/16; Lot #: 160303-10, BUD: 08/30/16. b) Lot #: 151203-37, BUD: 05/30/16; Lot #: 151203-72, BUD: 05/30/16; Lot #: 151209-7, BUD: 05/30/16; Lot #: 151209-8, BUD: 05/30/16; Lot #: 151209-9, BUD: 05/30/16; Lot #: 151209-10, BUD: 05/30/16; Lot #: 151209-11, BUD: 05/30/16; Lot #: 151209-13, BUD: 05/30/16; Lot #: 151209-14, BUD: 05/30/16; Lot #: 160104-31, BUD: 05/30/16; Lot #: 160113-77, BUD: 05/30/16; Lot #: 151218-7, BUD: 06/15/16; Lot #: 151218-8, BUD: 06/15/16; Lot #: 160113-78, BUD: 07/11/16; Lot #: 160113-4, BUD: 07/11/16; Lot #: 160122-10, BUD: 07/20/16; Lot #: 160201-6, BUD: 07/30/16; Lot #: 160201-7, BUD: 07/30/16; Lot #: 160204-9, BUD: 08/02/16; Lot #: 160208-5, BUD: 08/06/16; Lot #: 160208-6, BUD: 08/06/16; Lot #: 160210-65, BUD: 08/08/16; Lot #: 160210-66, BUD: 08/08/16; Lot #: 160210-67, BUD: 08/08/16; Lot #: 160210-68, BUD: 08/08/16; Lot #: 160210-69, BUD: 08/08/16; Lot #: 160303-12, BUD: 08/30/16; Lot #: 160303-13, BUD: 08/30/16; Lot #: 160309-2, BUD: 09/05/16.
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
- 2218 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-1181-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.