The Food & Drug Administration has discovered many issues with drug products that are meant to be sterile this year. The issues have often occurred at compounding pharmacies, which create specialized medical products for patients with unique needs. For instance, Specialty Compounding recently recalled all of its sterile medications due to reports about bacterial infections. Now, another compounding pharmacy is having issues with sterility assurance. Due to unclear lab methods used to test sterility, Park Pharmacy & Compounding Center is recalling two lots of Methylcobalamin and Multitrace-5 Concentrate vials.
According to the FDA, investigators have discovered that the pharmacies may have received inaccurate laboratory test results due to the manner in which sterility was assessed. The method of testing led to the FDA questioning if the results obtained by the laboratory are reliable. Park Pharmacy & Compounding Center states that “there have been no reported adverse events associated with the use of these products and there has been no confirmation of lack of sterility of these products.” However, if microbial contamination exists in the products that are intended to be sterile, then patients can contract life threatening bacterial infections.
The recall affects injectable forms of Methylcobalamin 5mg/ml 30ml Amber Vials Lot #06132013@1 Exp: 12/10/2013 and Multitrace-5 Concentrate 10ml Amber Vials Lot #05212013@20 Exp: 11/17/2013. The products are high doses of specific vitamins and minerals. According to Mayo Clinic, Methylcobalamin is a form of Vitamin B-12. The recalled products were sold directly to customers or to physician offices in June and July 2013. The products were only sold in California, Florida, New Mexico and Indiana.
Currently, the company is preparing for the return of all recalled product lots and is informing customers about the recall. The company recommends that consumers stop using the recalled products and contact the company for information on returning any unused product. Consumers can contact Park Pharmacy & Compounding at 949-551-7195 or by email at email@example.com weekdays 9 a.m. to 5 p.m. PST.
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