Recall Enforment Report D-0255-2022

Drug Recall Enforcement Report Class III voluntary initiated by UNICHEM PHARMACEUTICALS USA INC, originally initiated on 10-25-2021 for the product Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Road, Ghaziabad -201 003, India. Manufactured for: Unichem Pharmaceuticals (USA), Inc., East Brunswick, NJ 06815, NDC 29300-116-05. The product was recalled due to discoloration. The product was distributed nationwide and the recall is currently ongoing.

Field Name Field Value
Event ID 88891 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-0255-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Road, Ghaziabad -201 003, India. Manufactured for: Unichem Pharmaceuticals (USA), Inc., East Brunswick, NJ 06815, NDC 29300-116-05.
Reason For Recall Discoloration What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 1284 bottles Product Quantity
The amount of product subject to recall.
Voluntary Mandated Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date 12-01-2021
Recall Initiation Date 10-25-2021 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type Drugs
Recalling Firm UNICHEM PHARMACEUTICALS USA INC
Code Info Lot #: ZTPM20044, Exp. Date 09/30/2022 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages 29300-115-16; 29300-115-01; 29300-115-05; 29300-115-10; 29300-116-16; 29300-116-01; 29300-116-05; 29300-116-10; 29300-117-16; 29300-117-01; 29300-117-05; 29300-117-10; 29300-118-16; 29300-118-01; 29300-118-05; 29300-118-10
Status Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
29300-115Topiramate TopiramateTablet, Film CoatedOralUnichem Pharmaceuticals (usa), Inc.Human Prescription Drug
29300-116Topiramate TopiramateTablet, Film CoatedOralUnichem Pharmaceuticals (usa), Inc.Human Prescription Drug
29300-117Topiramate TopiramateTablet, Film CoatedOralUnichem Pharmaceuticals (usa), Inc.Human Prescription Drug
29300-118Topiramate TopiramateTablet, Film CoatedOralUnichem Pharmaceuticals (usa), Inc.Human Prescription Drug