FDAFDA · Food and drugs·Recall number 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. 08816. NDC 16571-742-41
Published February 14, 2024 · Recall initiated: February 1, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- NATCO Pharma Limited
- Distributor
- Nationwide in the USA
- Lot
- Lot # 411987 Exp: 05/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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