August 10, 2018
Several lots of doxycycline hyclate tablets are being recalled by 2 companies after samples failed to meet dissolution specifications, according to the August 8, 2018, US Food and Drug Administration (FDA) Enforcement Report.
West-Ward Columbus Inc. is recalling 50-count bottles of doxycycline hyclate tablets, USP, 100 mg (NDC 0143-2112-50), from lot 71545B, which expires January 2019. The firm is also recalling 500-count bottles of doxycycline cyclate tablets, USP, 100 mg (NDC 0143-2112-05), from lot 71545A, which expires July 2019.
In addition, Major Pharmaceuticals is pulling doxycycline hyclate tablets, USP, 100 mg, 30 tablets in 3x10 unit dose cartons (NDC 0904-0430-04), from lot 71545AA, which expires July 2019. The tablets were manufactured for Major Pharmaceuticals by West-Ward Pharmaceuticals Corporation.
Tablets from all 3 affected lots were distributed across the United States.
West-Ward Columbus initiated the voluntary recall July 24, 2018, and Major Pharmaceuticals followed suit July 30, 2018. On August 2, 2018, the FDA designated the recalls Class II, communicating that use of the affected tablets could cause temporary or medically reversible adverse health consequences. While remote, a possibility of serious harm also exists.
Doxycycline hyclate is a prescription tetracycline antibiotic used to treat various bacterial infections.
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