# FDA recall D-0429-2023

> **Accord Healthcare, Inc.** · Class II · drug recall initiated 2023-02-07.

## Product

rOPINIRole Tablets USP 3 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 16729-236-01, UPC 3 16729 23601 0

## Reason for recall

CGMP Deviations: recalling drug products following an FDA inspection.

## Distribution

United States including Puerto Rico and Canada

## Key facts

- **Recall number:** D-0429-2023
- **Recalling firm:** Accord Healthcare, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-02-07
- **Report date:** 2023-03-08
- **Termination date:** 2024-04-22

- **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-0429-2023

## Citation

> AI Analytics. FDA recall D-0429-2023. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0429-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*