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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