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Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: ...

FDA Recall #D-0807-2021 — Class II — August 6, 2021

Recall #D-0807-2021 Date: August 6, 2021 Classification: Class II Status: Terminated

Product Description

Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd., Bharuch-392130, India; Manufactured for: Torrent Pharma, Inc., Basking Ridge, NJ 07920; Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC 0904-6172-61

Reason for Recall

Failed Dissolution Specifications

Recalling Firm

The Harvard Drug Group — Livonia, MI

Classification

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

Product Type

Drugs

Product Quantity

4 Cartons of 100 count each

Distribution

NC

Code Information

Lot R01562; Exp. 10/2022

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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