BUSPIRONE HYDROCHLORIDE Recall D-0113-2024
Description: Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC 0615-7718-39), Rx only, Mfd By Pliva HRVATSKA for Teva USA, PKG by Vangard Glasgow, KY 42141.
BUSPIRONE HYDROCHLORIDE Recall D-0113-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0113-2024 |
| Event ID | 93336 |
| Brand | BUSPIRONE HYDROCHLORIDE |
| Generic Name | BUSPIRONE HYDROCHLORIDE |
| Manufacturer | BUSPIRONE HYDROCHLORIDE |
| Active Substance | BUSPIRONE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide USA |
| Quantity | 1,344 cards |
| Recall Reason | Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots |
| Drug Classification | Class III |
| Drug Code Info | 20231129 |
| Product NDC | 0615-7689 0615-7718 0615-7714 |
| Recall Initiation Date | 20231027 |
| Report Date | 20231129 |
| Classification Date | 20231121 |
| Address | 120 Carroll Knicely Dr Glasgow, KY 42141-7224 United States |
| Recalling Firm | NCS Healthcare of Kentucky Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 207LT9J9OC |
| Drug Application Number | ANDA075022 |
| Structured Product Labeling (SPL ID) | 6c110ec8-9544-4e3a-acb7-ac4f8ebbbeb2 |
| Structured Product Labeling (SPL Set ID) | 72bff09c-826e-4394-a7e7-41d56ce9605b |
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