FDA-Drug2023-03-08Class II
rOPINIRole Tablets USP 0.25 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 16729-232-01, UPC 3 16729 23201 2;
Accord Healthcare, Inc.
Hazard
CGMP Deviations: recalling drug products following an FDA inspection.
Sold states
United States including Puerto Rico and Canada
Affected count
139,332 bottles
Manufactured in
1009 Slater Rd Ste 210B, N/A, Durham, NC, United States
Products
rOPINIRole Tablets USP 0.25 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 16729-232-01, UPC 3 16729 23201 2;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0425-2023Don't want to check this manually?
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