Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 061
Summary
The FDA issued a Class III for Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-771 by NCS Healthcare of Kentucky Inc. Reason: Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots.
Details
Source
Drug Recall
External ID
D-0114-2024
Action Date
2023-11-29
Status
Terminated
Category
drug
Product Description
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.
Lot/Code Info: Lot#: a) 8255-3012, Exp 08/31/2024; b) 8255-3012, Exp 08/31/2024
Quantity Affected: 12 cards
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-27
Company
Glasgow, KY
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 38 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
NCS Healthcare of Kentucky Inc has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (NCS Healthcare of Kentucky Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does NCS Healthcare of Kentucky Inc have FDA actions?
NCS Healthcare of Kentucky Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0114-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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