Data Foundry

Drug recalls 2023

rOPINIRole Tablets USP 0 — Class II drug recall D-0426-2023

Terminated recall by Accord Healthcare, Inc., reported 2023-03-08, distributed in PR. CGMP Deviations: recalling drug products following an FDA inspection.

Recall numberD-0426-2023
Product typeDrug
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmAccord Healthcare, Inc., Durham, NC, United States
Recall initiated2023-02-07
Classified2023-03-02
Reported by FDA2023-03-08
Terminated2024-04-22
DistributedPR
Countries outside the USCA
Quantity181,848 bottles
Reason classescgmp
UPC / GTIN / UDI-DI00316729233019
NDC16729-0232, 16729-0232-01, 16729-0233, 16729-0233-01, 16729-0234, 16729-0234-01, 16729-0235, 16729-0235-01, 16729-0236, 16729-0236-01, 16729-0237, 16729-0237-01, 16729-0238, 16729-0238-01
Lot numbersP2102133, P2102135, P2102136, P2104990, P2104991, P2104992, P2104993, P2104997, P2104998, P2104999, P2105000, P2105001, P2105002, P2106812, P2200433, P2200434, P2200435, P2202729, P2202730, P2203517
Expiration dates2023-03-31, 2023-07-31, 2023-09-30, 2023-12-31, 2024-04-30, 2024-05-31

Product

rOPINIRole Tablets USP 0.5 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 16729-233-01, UPC 3 16729 23301 9

Reason for recall

CGMP Deviations: recalling drug products following an FDA inspection.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0426-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.