Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured
Summary
The FDA issued a Class I for Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles ( by Jubilant Cadista Pharmaceuticals, Inc.. Reason: Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled a.
Details
Source
Drug Recall
External ID
D-0767-2022
Action Date
2022-04-06
Status
Terminated
Category
drug
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
Lot/Code Info: Lot # 22P0036, Exp 12/2024
Quantity Affected: 12,174 bottles
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
Product was distributed in Arkansas, Florida, North Carolina, South Carolina and Ohio.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-08
Company
Salisbury, MD
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 81 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Jubilant Cadista Pharmaceuticals, Inc. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Jubilant Cadista Pharmaceuticals, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Jubilant Cadista Pharmaceuticals, Inc. have FDA actions?
Jubilant Cadista Pharmaceuticals, Inc. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0767-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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