Recalls / Class II
Class IID-1238-2016
Product
SELENIUM 200MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY
- Affected lot / code info
- Lot #: 151130-35, BUD: 05/21/16; Lot #: 151202-28, BUD: 05/21/16; Lot #: 151223-68, BUD: 05/21/16; Lot #: 151216-20, BUD: 05/21/16; Lot #: 151123-77, BUD: 05/21/16; Lot #: 151204-22, BUD: 05/21/16; Lot #: 160111-30, BUD: 05/21/16; Lot #: 160112-27, BUD: 05/21/16; Lot #: 160120-8, BUD: 05/21/16; Lot #: 160118-12, BUD: 05/21/16; Lot #: 160119-20, BUD: 05/21/16; Lot #: 160202-37, BUD: 05/21/16; Lot #: 160208-61, BUD: 05/21/16; Lot #: 160208-62, BUD: 05/21/16; Lot #: 160216-37, BUD: 08/14/16; Lot #: 160216-38, BUD: 08/14/16; Lot #: 160216-35, BUD: 08/14/16; Lot #: 160216-40, BUD: 08/14/16; Lot #: 160223-27, BUD: 08/14/16; Lot #: 160229-43, BUD: 08/14/16; Lot #: 160303-22, BUD: 08/14/16; Lot #: 160309-17, BUD: 08/14/16
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
- 884 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-1238-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.