Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only, Abrams Royal Compounding Pharmacy, 8220 Abrams Rd, Dallas, TX 75231.
FDA recall notice · announced November 26, 2014 · Abrams Royal Pharmacy
Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.
The 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.
Notes
Distribution: Two hospitals in Dallas, TX
Lot/code information: Lot #: 05152013@4 (also written as 051513-4), Exp 11/11/13
Quantity: 1,100 vials
Status: Terminated
Products in this recall event:
- Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only, Abrams Royal Compounding Pharmacy, 8220 Abrams Rd, Dallas, TX 75231. (D-0250-2015)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.