Recalls / Class II
Class IID-1182-2016
Product
EDTA DISODIUM 15% (150MG/ML), 20ML Vials, MEDAUS PHARMACY
- Affected lot / code info
- Lot #: 151202-45, BUD: 05/30/16; Lot #: 160105-38, BUD: 07/03/16; Lot #: 160114-20, BUD: 07/12/16; Lot #: 160217-28, BUD: 08/15/16
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
- 24000 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-1182-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.