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Class II: temporary or reversible health riskTerminated

Torrent Pharma Carbamazepine Tablets Recall

Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by:…

Torrent Pharma Inc. · Basking Ridge, NJ

Risk level
Class II
Reported by FDA
Jan 19, 2022
Recall ID
D-0365-2022
Check your lot numberHow we source this data

Summary

Torrent Pharma recalled Carbamazepine Tablets starting Dec 2, 2021. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0365-2022 on Jan 19, 2022. Reason: Failed Dissolution Specifications. Status: Terminated.

Why it was recalled

Failed Dissolution Specifications

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 numbers, UPCs & expiration codes

Batch: 4J11G002 Exp. 08/2024

Where it was sold

Nationwide USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0365-2022
Classification
Class II
Status
Terminated
Recall initiated
Dec 2, 2021
FDA report date
Jan 19, 2022
Quantity
15,336 Bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Torrent Pharma Inc.

Original FDA data

Every field from FDA enforcement report D-0365-2022, exactly as published.

Show all FDA fields
City
Basking Ridge
State
NJ
Status
Terminated
Country
United States
Event ID
89146
Address
150 Allen Rd Ste 102
Code information
Batch: 4J11G002 Exp. 08/2024
Postal code
07920-3856
Report date
Jan 19, 2022
Product type
Drugs
Recall number
D-0365-2022
Classification
Class II
Recalling firm
Torrent Pharma Inc.
Product quantity
15,336 Bottles
Termination date
Oct 23, 2023
Reason for recall
Failed Dissolution Specifications
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
Nationwide USA
Recall initiation date
Dec 2, 2021
Initial firm notification
Letter
Center classification date
Jan 11, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0365-2022, published Jan 19, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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