FDA Recall D-0250-2015
Abrams Royal Pharmacy · Dallas, TX
Class I — life-threatening Terminated 1160 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only, Abrams Royal Compounding Pharmacy, 8220 Abrams Rd, Dallas, TX 75231.
Reason for recall
Non-Sterility: The firm's contract testing laboratory found sterility failures.
Recall record
- Recall number
D-0250-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- Two hospitals in Dallas, TX
- Recall initiated
- 2013-05-31
- Classified by FDA Center
- 2014-11-17
- FDA published
- 2014-11-26
- Terminated
- 2016-08-03
- Recalling firm
- Abrams Royal Pharmacy
- Firm location
- Dallas, TX