Recalls / Class II
Class IID-0737-2022
Product
Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle, (55111-398-90), Rx Only, Manufactured. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India
- Brand name
- Lansoprazole
- Generic name
- Lansoprazole
- Active ingredient
- Lansoprazole
- Route
- Oral
- NDCs
- 55111-398, 55111-399
- FDA application
- ANDA091269
- Affected lot / code info
- Lot # a) C2103093, Exp. 12/2023; b)C2103092, Exp. 12/2023.
Why it was recalled
Failed Dissolution Specifications; during long term stability testing.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr.Reddy's Laboratories Ltd.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 8,352 bottles (30-count), 1,368 bottles (90-count)
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-03-23
- FDA classified
- 2022-03-31
- Posted by FDA
- 2022-04-06
- Terminated
- 2024-02-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0737-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.