Recalls / Class II
Class IID-0074-2021
Product
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), 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
- Lot # M005681, EXP 3/2022
Why it was recalled
Failed Dissolution Specification
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
- 6,840 units
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2020-10-27
- FDA classified
- 2020-11-10
- Posted by FDA
- 2020-11-11
- Terminated
- 2022-12-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0074-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.