Allopurinol Tablet
FDA Recall NDC 16729-134
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Allopurinol (NDC 16729-134). A significant event, classified as Class II, was initiated on Jan 12, 2023 by Accord Healthcare Inc.. The reported reason for this action was: "Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Jan 12, 2023
Feb 01, 2023
87,576 bottles
Recall Profile & Regulatory Data
Event ID
91499
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Apr 23, 2024
Product Description
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
16729-134-10Product
16729-134-01Product
16729-134-16Product
16729-134-17Product
16729-135-10Product
16729-135-01Product
16729-135-16Product
16729-135-17Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
