FDARecalled Feb 14, 2024 · #D-0318-2024
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. 088...
Hazard
Class II — temporary health risk
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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. Classification: Class II Distribution: Nationwide in the USA
Product details
- 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
- Type
- Drugs
- Manufacturer
- NATCO Pharma Limited
- Model numbers
- 411987
- UPCs
- —