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

FDA Recall #D-0365-2022 — Class II — December 2, 2021

Recall #D-0365-2022 Date: December 2, 2021 Classification: Class II Status: Terminated

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.

Reason for Recall

Failed Dissolution Specifications

Recalling Firm

Torrent Pharma Inc. — Basking Ridge, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

15,336 Bottles

Distribution

Nationwide USA

Code Information

Batch: 4J11G002 Exp. 08/2024

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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