Reported Feb 14, 2024 · Terminated
Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509…
NATCO Pharma Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NATCO Pharma Limited · Pharma Division, Kothur Village · Rangareddy · N/A
Is this the product you have?
Lansoprazole Delayed-Release Capsules USP15 mg14-count bottle
- Manufactured byNatco Pharma Limited Kothur- 509 228, India
- Distributed byRising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41
- Lot codes and dates
- Lot # 411987
- Exp05/2025
- Amount recalled
- 4260 bottles
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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