Product Safety Recalls

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ROPINIROLE HYDROCHLORIDE Recall D-0425-2023

Description: 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;

ROPINIROLE HYDROCHLORIDE Recall D-0425-2023 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0425-2023
Event ID91657
BrandROPINIROLE
Generic NameROPINIROLE
ManufacturerROPINIROLE
Original Package?1
Active SubstanceROPINIROLE HYDROCHLORIDE
Drug RouteORAL
DistributionUnited States including Puerto Rico and Canada
Quantity139,332 bottles
Recall ReasonCGMP Deviations: recalling drug products following an FDA inspection.
Drug ClassificationClass II
Drug Code Info20230308
Product NDC16729-232 16729-233 16729-234
Drug UPC316729232012
Recall Initiation Date20230207
Report Date20230308
Classification Date20230302
Address1009 Slater Rd Ste 210B
Durham, NC 27703-8446
United States
Recalling FirmAccord Healthcare, Inc.
Initial Notification Letter
Unique Ingredient IdentifierD7ZD41RZI9
Drug Application NumberANDA204022
Structured Product Labeling (SPL ID)ecb5df9f-8d52-d0a3-e053-2995a90a30ab
Structured Product Labeling (SPL Set ID)4a2a5b63-5b14-6975-e054-00144ff8d46c
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