FDA Recall D-1563-2014
Abrams Royal Pharamacy · Dallas, TX
Class I — life-threatening Terminated 1023 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX
Reason for recall
Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis
Recall record
- Recall number
D-1563-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide and to Canada
- Recall initiated
- 2013-12-19
- Classified by FDA Center
- 2014-08-25
- FDA published
- 2014-09-03
- Terminated
- 2016-10-07
- Recalling firm
- Abrams Royal Pharamacy
- Firm location
- Dallas, TX