Recalls / Class II
Class IID-0145-2021
Product
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-771-77
- Brand name
- Lansoprazole
- Generic name
- Lansoprazole
- Active ingredient
- Lansoprazole
- Route
- Oral
- NDCs
- 68382-771, 68382-772
- FDA application
- ANDA200816
- Affected lot / code info
- M915744 OCT 2021 M904770 FEB 2021
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Zydus Pharmaceuticals (USA) Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 15,144 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2020-12-03
- FDA classified
- 2020-12-11
- Posted by FDA
- 2020-12-23
- Terminated
- 2022-12-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0145-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.