Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd. Bha
Summary
The FDA issued a Class II for Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactu by Torrent Pharma Inc.. Reason: Failed Dissolution Specifications.
Details
Source
Drug Recall
External ID
D-0365-2022
Action Date
2022-01-19
Status
Terminated
Category
drug
Product Description
Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd. Bharuch-392130, India Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920.
Lot/Code Info: Batch: 4J11G002 Exp. 08/2024
Quantity Affected: 15,336 Bottles
Reason for Recall
Failed Dissolution Specifications
Distribution
Nationwide USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-02
Company
Basking Ridge, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 66 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Torrent Pharma Inc. has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (Torrent Pharma Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Torrent Pharma Inc. have FDA actions?
Torrent Pharma Inc. has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0365-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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