D-0113-2024 Class III Terminated
FDA drug recall D-0113-2024 was initiated by NCS Healthcare Of Kentucky Inc on Oct 27, 2023 and is designated Class III. Reason for recall: Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots The recall status is terminated (terminated Jul 14, 2024). Affected quantity: 1,344 cards.
Recall details
- Product Type
- Drugs
- Report Date
- Nov 29, 2023
- Initiation Date
- Oct 27, 2023
- Termination Date
- Jul 14, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,344 cards
Product 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.
Reason for recall
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Distribution pattern
Nationwide USA
Code information
Lot#: a) 7718-3008, Exp 08/31/2024; b) 7718-3008, Exp 08/31/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0113-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026