NATCO Pharma Limited recalls Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228
Recalled February 14, 2024 · FDA recall D-0318-2024 · NATCO Pharma
Hazard
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. · FDA Class II
Units
4260 bottles
Sold at
Nationwide in the USA
Description
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.
Product
Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41
Manufacturer(s)
NATCO Pharma Limited
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →