PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: February 1, 2023 Initiated: January 12, 2023 #D-0168-2023

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

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.

Details

Recalling Firm
Accord Healthcare, Inc.
Units Affected
87,576 bottles
Distribution
Nationwide in the USA
Location
Durham, NC

Frequently Asked Questions

What product was recalled?
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. Recalled by Accord Healthcare, Inc.. Units affected: 87,576 bottles.
Why was this product recalled?
Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 1, 2023. Severity: Moderate. Recall number: D-0168-2023.