FDA recall D-0431-2023

Product

rOPINIRole Tablets USP 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 16729-238-01, UPC 3 16729 23801 4

Reason for recall

CGMP Deviations: recalling drug products following an FDA inspection.

Distribution

United States including Puerto Rico and Canada

Key facts

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0431-2023