# FDA recall D-0168-2023

> **Accord Healthcare, Inc.** · Class II · drug recall initiated 2023-01-12.

## 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.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0168-2023
- **Recalling firm:** Accord Healthcare, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-01-12
- **Report date:** 2023-02-01
- **Termination date:** 2024-04-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Durham, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0168-2023

## Citation

> AI Analytics. FDA recall D-0168-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0168-2023. Source: US FDA. Licensed CC0.

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