Recalls / Class II
Class IID-1242-2016
Product
TESTOSTERONE CYP 200 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML, and e) 5ML Vials, MEDAUS PHARMACY
- Affected lot / code info
- a) Lot #151210-5, BUD: 06/07/16; Lot #160204-31, BUD: 08/02/16; Lot #160107-8, BUD: 07/05/16; Lot #160303-47, BUD: 08/30/16. b) Lot #151210-5, BUD: 06/07/16; Lot #160107-8, BUD: 07/05/16; Lot #160204-31, BUD: 08/02/16; Lot #160303-47, BUD: 08/30/16. c) Lot #151207-8, BUD: 06/04/16; Lot #160303-47, BUD: 08/30/16; Lot #151210-5, BUD: 06/07/16; Lot #160107-8, BUD: 07/05/16; Lot #160204-31, BUD: 08/02/16; Lot #160106-34, BUD: 07/04/16; Lot#160208-22, BUD: 08/06/16. d) Lot #151210-5, BUD: 06/07/16; Lot #160107-8, BUD: 07/05/16; Lot #160204-31, BUD: 08/02/16; Lot #160303-47, BUD: 08/30/16. e) Lot #151210-5, BUD: 06/07/16; Lot #160107-8, BUD: 07/05/16; Lot #160204-31, BUD: 08/02/16; Lot #160303-47, BUD: 08/30/16.
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
- 8000 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-1242-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.