FDA-Drug2024-02-14Class II
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
NATCO Pharma Limited
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.
Sold states
Nationwide in the USA
Affected count
4260 bottles
Manufactured in
Pharma Division, Kothur Village, Rangareddy, India
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0318-2024Don't want to check this manually?
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