Drug Enforcement D-0113-2024

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

Status

Terminated

Classification

Class III

Report Date

November 29, 2023

Termination Date

July 14, 2024

Product Information

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.
Product quantity
1,344 cards
Reason for recall
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide USA

Location & Firm

Recalling firm
NCS Healthcare of Kentucky Inc
Address
120 Carroll Knicely Dr, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0113-2024
Event ID
93336
Recall initiation date
October 27, 2023
Center classification date
November 21, 2023
Code info
Lot#: a) 7718-3008, Exp 08/31/2024; b) 7718-3008, Exp 08/31/2024
More code info
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