June 19, 2020
Three lots of 100-mg doxycycline hyclate tablets are being recalled by American Health Packaging because samples failed to meet dissolution specifications during routine testing. The recall was included in the June 17, 2020, US Food and Drug Administration (FDA) Enforcement Report.
“This recall is being initiated in support of the recall by the manufacturer (West-Ward Columbus Inc., a Hikma Company) dated May 13, 2020, which included lots that were repackaged by American Health Packaging,” American Health Packaging explained in a May 19, 2020, letter announcing the recall.
The recall affects doxycycline hyclate tablets, 100 mg, 30 tablets per carton (carton NDC 62584-693-21, unit dose NDC 62584-693-11) from lots 179605 (Exp. 6/30/20), 181105 (Exp. 8/31/20), and 183019 (Exp. 1/31/21). The tablets were distributed throughout the United States.
American Health Packaging initiated the voluntary recall May 19, 2020. On June 8, 2020, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.
Doxycycline is a prescription antibiotic used to treat bacterial infections.