March 2022 FDA Recall Meclizine Hydrochloride by Jubilant Cadista Pharmaceuticals, Inc.
D-0767-2022 - Labeling
This Class I drug recall was voluntarily initiated by Jubilant Cadista Pharmaceuticals, Inc. on March 8, 2022 for the product Meclizine Hydrochloride. The FDA reported the reason for recall as labeling. The product was distributed in Product was distributed in Arkansas, Florida, North Carolina, South Carolina and Ohio. and the recall is currently terminated.
Recall Number: D-0767-2022
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
03-08-2022
04-06-2022
12,174 bottles
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Jubilant Cadista Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed in Arkansas, Florida, North Carolina, South Carolina and Ohio.
11-15-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# 22P0036, Exp 12/2024
