Recalls / Class III
Class IIID-0113-2024
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.
- Brand name
- Buspirone Hydrochloride
- Generic name
- Buspirone Hydrochloride
- Active ingredient
- Buspirone Hydrochloride
- Route
- Oral
- NDCs
- 0615-7689, 0615-7714, 0615-7718
- FDA application
- ANDA075022
- Affected lot / code info
- Lot#: a) 7718-3008, Exp 08/31/2024; b) 7718-3008, Exp 08/31/2024
Why it was recalled
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Recalling firm
- Firm
- NCS Healthcare of Kentucky Inc
- Manufacturer
- NCS HealthCare of KY, LLC dba Vangard Labs
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 120 Carroll Knicely Dr, N/A, Glasgow, Kentucky 42141-7224
Distribution
- Quantity
- 1,344 cards
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2023-10-27
- FDA classified
- 2023-11-21
- Posted by FDA
- 2023-11-29
- Terminated
- 2024-07-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0113-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.