FDA recall D-0113-2024

NCS Healthcare of Kentucky Inc · Class III · 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.

Reason for recall

Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots

Distribution

Nationwide USA

Key facts

Status
Terminated
Initiation date
2023-10-27
Report date
2023-11-29
Termination date
2024-07-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Glasgow, KY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0113-2024