BUSPIRONE HYDROCHLORIDE Recall D-0376-2023
Description: BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Tablets NDC 16729-200-01 UPC 3 16729 20001 1; b) 500 Tablets NDC 16729-200-16 UPC 3 16729 20016 5; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
BUSPIRONE HYDROCHLORIDE Recall D-0376-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0376-2023 |
| Event ID | 91657 |
| Brand | BUSPIRONE HYDROCHLORIDE |
| Generic Name | BUSPIRONE HYDROCHLORIDE |
| Manufacturer | BUSPIRONE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | BUSPIRONE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | United States including Puerto Rico and Canada |
| Quantity | 24,408 bottles |
| Recall Reason | CGMP Deviations: recalling drug products following an FDA inspection. |
| Drug Classification | Class II |
| Drug Code Info | 20230308 |
| Product NDC | 16729-200 16729-201 16729-202 |
| Drug UPC | 0316729289122 316729200011 316729200165 |
| 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 | 207LT9J9OC |
| Drug Application Number | ANDA202557 |
| Structured Product Labeling (SPL ID) | e98fd656-850d-e2bc-e053-2995a90ae7ac |
| Structured Product Labeling (SPL Set ID) | 3da22999-f5fb-49fd-acde-c3006598e985 |
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