Meclizine Hydrochloride Tablet
FDA Recall NDC 59746-121
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Meclizine Hydrochloride (NDC 59746-121). A significant event, classified as Class I, was initiated on Mar 08, 2022 by Jubilant Cadista Pharmacuticals Inc.. The reported reason for this action was: "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"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
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
Mar 08, 2022
Apr 06, 2022
12,174 bottles
Recall Profile & Regulatory Data
Event ID
89854
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Jubilant Cadista Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed in Arkansas, Florida, North Carolina, South Carolina and Ohio.
Termination Date
Nov 15, 2022
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
Batch or Lot Expiration Information
Lot# 22P0036, Exp 12/2024
Affected Packages Involved in this Recall
59746-122-06Product
59746-122-10Product
59746-121-06Product
59746-121-10Product
Class III Terminated
Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
Oct 30, 2017
Nov 22, 2017
744 bottles
Recall Profile & Regulatory Data
Event ID
78461
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Jubilant Cadista Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 12, 2020
Product Description
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
Affected Packages Involved in this Recall
59746-122-06Product
59746-122-10Product
59746-121-06Product
59746-121-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
