ROPINIROLE HYDROCHLORIDE Recall D-0428-2023
Description: rOPINIRole Tablets USP 2 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 16729-235-01, UPC 3 16729 23501 3
ROPINIROLE HYDROCHLORIDE Recall D-0428-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0428-2023 |
| Event ID | 91657 |
| Brand | ROPINIROLE |
| Generic Name | ROPINIROLE |
| Manufacturer | ROPINIROLE |
| Original Package? | 1 |
| Active Substance | ROPINIROLE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | United States including Puerto Rico and Canada |
| Quantity | 25,344 bottles |
| Recall Reason | CGMP Deviations: recalling drug products following an FDA inspection. |
| Drug Classification | Class II |
| Drug Code Info | 20230308 |
| Product NDC | 16729-232 16729-233 16729-234 |
| Drug UPC | 316729235013 |
| Recall Initiation Date | 20230207 |
| Report Date | 20230308 |
| Classification Date | 20230302 |
| Address | 1009 Slater Rd Ste 210B Durham, NC 27703-8446 United States |
| Recalling Firm | Accord Healthcare, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | D7ZD41RZI9 |
| Drug Application Number | ANDA204022 |
| 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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