February 26, 2021
Product samples failing to meet dissolution specifications during routine testing have prompted Wilshire Pharmaceuticals Inc. to voluntarily recall more than 38,000 bottles of meclizine hydrochloride tablets distributed in Florida and Texas. The recall was announced in the February 24, 2021, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following products:
- meclizine hydrochloride tablets, 12.5 mg, 100-tablet bottles (NDC 52536-129-01), from lot 18030318 (Exp. 3/21); and
- meclizine hydrochloride tablets, 25 mg, 100-tablet bottles (NDC 52536-133-01), from lots 18030329, 18030330, and 18030331 (Exp. 3/21).
Wilshire Pharmaceuticals initiated the recall February 4, 2021. The FDA designated the recall Class II on February 16, 2021. 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.
Meclizine is a prescription antihistamine used to treat symptoms of vertigo.