FDA November 26, 2014 Enforcement Report Includes Findings on Abrams Royal Pharmacy

Product TypeProduct DescriptionCode InfoClassificationReason for RecallRecalling FirmDrugs Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only, Abrams Royal Compounding Pharmacy, 8220 Abrams Rd, Dallas, TX 75231. Lot #: 05152013@4 (also written as 051513-4), Exp 11/11/13 Class I Non-Sterility: The firm's contract testing laboratory found sterility failures. Abrams Royal Pharmacy
Drugs Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL/Hyaluronidase13.64 u/mL, supplied in 11 mL Sterile Syringes, Rx only, Compounded med, Single use only, (Red Block) ABRAMS ROYAL Compounding Pharmacy, Dallas, TX Lot# 041013-13 (also been written as "041013@13") Exp: 06/09/2013 Class I Non-Sterility Abrams Royal Pharmacy
Drugs Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as sulfate), 0.4 mg Copper (as sulfate), 0.1 mg Manganese (as sulfate), 4 mcg Chromium (as chloride), 20 mcg Selenium (as sodium), 0.9% Benzyl alcohol in water for injection, Rx Only, Compounded Medication, ABRAMS ROYAL Compounding Pharmacy, Dallas, TX Lot number 04302013@21 (also written as 043013-21), exp 10/27/2013 Class I Non-Sterility; contract laboratory identified Staphylococcus warneri in the product Abrams Royal Pharmacy