PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: April 17, 2024 Initiated: March 27, 2024 #D-0438-2024

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

Reason for Recall

CGMP Deviations

Details

Recalling Firm
NATCO Pharma Limited
Units Affected
30 bottles
Distribution
Nationwide in the US
Location
Rangareddy, N/A

Frequently Asked Questions

What product was recalled?
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. Recalled by NATCO Pharma Limited. Units affected: 30 bottles.
Why was this product recalled?
CGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on April 17, 2024. Severity: Moderate. Recall number: D-0438-2024.