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Recall Observatory FDA recall evidence

Drug 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.

D-0250-2015

May 31, 2013

Class I

Product summary

Firm
Abrams Royal Pharmacy
Event
Event 68283
Status
Terminated
Classification
Class I
Quantity
1,100 vials
Official record key
drug-enforcement:D-0250-2015

Official wording

Reason: Non-Sterility: The firm's contract testing laboratory found sterility failures.

Code information: Lot #: 05152013@4 (also written as 051513-4), Exp 11/11/13

Distribution pattern: Two hospitals in Dallas, TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Non-Sterility: The firm's contract testing laboratory found sterility failures.