Outsourcing Pharmacy Asks Court To Restrain FDA From Shutting It Down Over Contamination
A Little Rock, Arkansas, outsourcing pharmacy continued to defy FDA even after the agency went to court for an injunction to shut down the pharmacy's drug compounding operations over continued lack of sterility. Cantrell Drug Co. could have accepted proposed consent decree terms but instead countered in federal bankruptcy court with an injunction request of its own.
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FDA Warns Consumers Not To Use Sterile Drugs Made By Pacifico National After Firm Refuses Recall Requests
After Melbourne, Florida, outsourcer resisted entreaties to recall sterile drugs over contamination and eye infections, the FDA warned consumers not to use sterile drugs compounded by the firm, Pacifico National, doing business as AmEx Pharmacy.
Opioid crisis gives US FDA something heparin crisis couldn’t: more drug recall authority in some cases. Meanwhile, Hanlim warning letter and Mercury Labs and Recipharm EU GMP non-compliance statements prove illuminating.
Drug compounding pharmacy Isomeric has entered a consent decree after turning a blind eye to a multitude of GMP problems with its injectable and ophthalmic drugs. This brings to six the number of consent decrees the Justice Department has reached with compounding pharmacies since the New England Compounding Center tragedy in 2012.