Drug product
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.
D-0113-2024
Product summary
- Event
- Event 93336
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,344 cards
- Official record key
drug-enforcement:D-0113-2024
Official wording
Reason: Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Code information: Lot#: a) 7718-3008, Exp 08/31/2024; b) 7718-3008, Exp 08/31/2024
Distribution pattern: Nationwide USA
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets