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Recall Enforment Report D-0231-2015

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Specialty Compounding, LLC, originally initiated on 08-09-2013 for the product All products, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613 The product was recalled due to lack of assurance of sterility. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0231-201508-09-201311-05-2014Class IIUndeterminedAll products, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613Lack of Assurance of SterilityTerminated
D-0230-201508-09-201311-05-2014Class IUndeterminedCALCIUM GLUCONATE 2 gm (PF) PRESERVATIVE FREE in 100 mL Sodium Chloride 0.9% for Injection, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613Non Sterility: Microbial contaminationTerminated