October 2017 FDA Recall Meclizine Hydrochloride by Jubilant Cadista Pharmaceuticals, Inc.
D-0082-2018 - Marketed without an approved NDA/ANDA
This Class III drug recall was voluntarily initiated by Jubilant Cadista Pharmaceuticals, Inc. on October 30, 2017 for the product Meclizine Hydrochloride. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0082-2018
Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
10-30-2017
11-22-2017
744 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
02-12-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06
Batch or Lot Expiration Information
Lot# 17P0430, Exp 05/19
