NATCO Pharma Limited: Drug Recall

Recall #D-0438-2024 · 03/27/2024

Class II: Risk

Recall Details

Recall Number: D-0438-2024
Classification: Class II
Product Type: Drug
Recalling Firm: NATCO Pharma Limited
Status: Terminated
Date Initiated: 03/27/2024
Location: Rangareddy, N/A, India
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 30 bottles

Reason for Recall

CGMP Deviations

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

Distribution Pattern

Nationwide in the US

Other Recalls by NATCO Pharma Limited

Class II: Risk 02/01/2024

CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.

View all recalls by NATCO Pharma Limited →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.