June 12, 2020
The Harvard Drug Group is recalling more than 16,000 cartons of 100-mg doxycycline hyclate tablets manufactured by West-Ward Pharmaceutical Corp. According to the June 10, 2020, US Food and Drug Administration (FDA) Enforcement Report, the tablets failed to meet dissolution specifications during routine testing.
The recall affects the following products, which were distributed throughout the United States by Major Pharmaceuticals:
- doxycycline hyclate tablets, 100 mg, packaged in 3 x 10 unit dose cartons (NDC 0904-0430-04) from lot R00828D (Exp. 8/20), and
- doxycycline hyclate tablets, 100 mg, packaged in 5 x 10 unit dose carton (NDC 0904-0430-06) from lots R00732D (Exp. 5/20), R00783D (Exp. 6/20), and R00827D (Exp. 8/20).
The Harvard Drug Group initiated the voluntary recalls May 22, 2020. On June 4, 2020, the FDA designated the recalls Class II. Under Class II recalls, use of the affected tablets could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.
Doxycycline is a prescription antibiotic used to treat bacterial infections.