D-0767-2022 Class I Terminated

Recalled by Jubilant Cadista Pharmaceuticals, Inc. — Salisbury, MD

Recall Details

Product Type
Drugs
Report Date
April 6, 2022
Initiation Date
March 8, 2022
Termination Date
November 15, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12,174 bottles

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

Lot # 22P0036, Exp 12/2024