January 2023 FDA Recall Allopurinol by Accord Healthcare, Inc.
D-0168-2023 - Presence of Foreign Substance

This Class II drug recall was voluntarily initiated by Accord Healthcare, Inc. on January 12, 2023 for the product Allopurinol. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0168-2023

Reason for Recall
Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Initiated
01-12-2023
Reported
02-01-2023
Quantity
87,576 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91499
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.
Accord Healthcare, Inc.
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-23-2024
Product Description About Product Description
Full technical description of the product.
Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India. NDC 16729-134-01

Batch or Lot Expiration Information

Lot# Lots: R2200455, R2200456 Exp. 03/2025

Affected Packages Involved in this Recall

16729-134-10 Allopurinol
16729-134-01 Allopurinol
16729-134-16 Allopurinol
16729-134-17 Allopurinol
16729-135-10 Allopurinol
16729-135-01 Allopurinol
16729-135-16 Allopurinol
16729-135-17 Allopurinol