Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottl
Summary
The FDA issued a Class II for Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats F by NATCO Pharma Limited. Reason: CGMP Deviations.
Details
Source
Drug Recall
External ID
D-0438-2024
Action Date
2024-04-17
Status
Terminated
Category
drug
Product Description
Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41
Lot/Code Info: Lot#: 411988, Exp date: 05/31/2025
Quantity Affected: 30 bottles
Reason for Recall
CGMP Deviations
Distribution
Nationwide in the US
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-27
Company
Rangareddy, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 36 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
NATCO Pharma Limited has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (NATCO Pharma Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does NATCO Pharma Limited have FDA actions?
NATCO Pharma Limited 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-0438-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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