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Class II: temporary or reversible health riskTerminated

Torrent Pharma Carbamazepine Tablets Recall

Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufacture…

Torrent Pharma Inc. · Basking Ridge, NJ

Risk level
Class II
Reported by FDA
Jun 10, 2020
Recall ID
D-1317-2020
Check your lot numberHow we source this data

Summary

Torrent Pharma recalled Carbamazepine Tablets starting May 11, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1317-2020 on Jun 10, 2020. Reason: Failed Dissolution Specifications. Status: Terminated.

Why it was recalled

Failed Dissolution Specifications

Product description

Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd, Bharuch 392130, India; Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-268-05

Lot numbers, UPCs & expiration codes

Lot #: 4FF4F001, Exp 1/2023

Where it was sold

USA Nationwide and Puerto Rico

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-1317-2020
Classification
Class II
Status
Terminated
Recall initiated
May 11, 2020
FDA report date
Jun 10, 2020
Quantity
6228 Bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Torrent Pharma Inc.

Original FDA data

Every field from FDA enforcement report D-1317-2020, exactly as published.

Show all FDA fields
City
Basking Ridge
State
NJ
Status
Terminated
Country
United States
Event ID
85644
Address
150 Allen Rd Ste 102
Code information
Lot #: 4FF4F001, Exp 1/2023
Postal code
07920-3856
Report date
Jun 10, 2020
Product type
Drugs
Recall number
D-1317-2020
Classification
Class II
Recalling firm
Torrent Pharma Inc.
Product quantity
6228 Bottles
Termination date
Aug 10, 2022
Reason for recall
Failed Dissolution Specifications
Voluntary / mandated
Voluntary: Firm initiated
Product description
Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd, Bharuch 392130, India; Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-268-05
Distribution pattern
USA Nationwide and Puerto Rico
Recall initiation date
May 11, 2020
Initial firm notification
Letter
Center classification date
Jun 18, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1317-2020, published Jun 10, 2020. 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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