Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only, Abrams Royal Compounding Pharmacy, 8220 Abrams Rd, Dallas, TX 75231.

Recall Insight

This FDA Drug action (record #D-0250-2015) was formally reported on November 26, 2014, with the manufacturer initiating the action on May 31, 2013. It is classified under Critical severity (Class I), with a current status of Terminated. Abrams Royal Pharmacy is listed as the recalling firm, operating out of Dallas, TX. Federal records indicate 1,100 vials units are affected.

The documented reason for this recall is: Non-Sterility: The firm's contract testing laboratory found sterility failures. Distribution data in the federal record shows the product reached: Two hospitals in Dallas, TX. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.