Meclizine Hydrochloride Tablets USP recalled over labeling errors

Recall date

March 8, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Jubilant Cadista Pharmaceuticals, Inc. recalls Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufacture…

Recall number

D-0767-2022

FDA classification

Class I

Brand / firm

Jubilant Cadista Pharmaceuticals, Inc.

Sold / distributed

Product was distributed in Arkansas, Florida, North Carolina, South Carolina and Ohio.

Why it was recalled

Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801, NDC 59746-122-06