August 2021 FDA Recall Carbamazepine by The Harvard Drug Group
D-0807-2021 - Failed Dissolution Specifications

This Class II drug recall was voluntarily initiated by The Harvard Drug Group on August 6, 2021 for the product Carbamazepine. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed in NC and the recall is currently terminated.

Recall Number: D-0807-2021

Reason for Recall
Failed Dissolution Specifications
Initiated
08-06-2021
Reported
09-29-2021
Quantity
4 Cartons of 100 count each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88583
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Harvard Drug Group
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-08-2022
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# Lot R01562; Exp. 10/2022

Affected Packages Involved in this Recall

0904-3854-61 Carbamazepine
0904-3854-80 Carbamazepine
0904-6172-61 Carbamazepine
0904-6172-50 Carbamazepine