Multi-event October 2023 FDA Recall Buspirone Hydrochloride by Ncs Healthcare Of Kentucky Inc
This Multi-event Class III drug recall was voluntarily initiated by Ncs Healthcare Of Kentucky Inc on October 27, 2023 for the product Buspirone Hydrochloride. The FDA reported the reason for recall as presence of foreign tablets. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0113-2024
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
10-27-2023
11-29-2023
1,344 cards
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NCS Healthcare of Kentucky Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide USA
07-14-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# : a) 7718-3008, Exp 08/31/2024; b) 7718-3008, Exp 08/31/2024
Affected Packages Involved in this Recall
Recall Number: D-0114-2024
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
10-27-2023
11-29-2023
12 cards
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NCS Healthcare of Kentucky Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide USA
07-14-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 0615-8255-39), Rx only, Mfd By Lupin, PKG by Vangard Glasgow, KY 42141.
Batch or Lot Expiration Information
Lot# : a) 8255-3012, Exp 08/31/2024; b) 8255-3012, Exp 08/31/2024
