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

FDA recall notice · announced February 1, 2023 · Accord Healthcare

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

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

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.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lots: R2200455, R2200456 Exp. 03/2025
Quantity: 87,576 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0168-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.