Key Takeaway

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. Ind by Accord Healthcare, Inc. was recalled on January 12, 2023. The hazard: Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.

FDA Drug 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. Ind

Recalled: January 12, 2023 ~87,576 bottles units affected D-0168-2023

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

Hazard / Reason

Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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. Ind

Drugs

Company Information

Accord Healthcare, Inc.

Durham, NC, United States

View all 93 recalls by Accord Healthcare, Inc. →

Distribution

Nationwide in the USA

Related Recalls

Frequently Asked Questions

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