NATCO Pharma Limited: Drug Recall
Recall #D-0318-2024 · 02/01/2024
Class II: Risk
Recall Details
- Recall Number
- D-0318-2024
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- NATCO Pharma Limited
- Status
- Terminated
- Date Initiated
- 02/01/2024
- Location
- Rangareddy, India
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4260 bottles
Reason for Recall
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 Description
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
Distribution Pattern
Nationwide in the USA
Other Recalls by NATCO Pharma Limited
- Class II: Risk 03/27/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.