Recalls / Class II
Class IID-0853-2022
Product
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister pack, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, NDC 43598-561-78.
- Brand name
- Lansoprazole
- Generic name
- Lansoprazole
- Active ingredient
- Lansoprazole
- Route
- Oral
- NDCs
- 43598-561, 43598-560
- FDA application
- ANDA210465
- Affected lot / code info
- Lot #: T2000645, Exp 07/2022
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr.Reddys Laboratories Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 252 Blister Packs
- Distribution pattern
- OH
Timeline
- Recall initiated
- 2022-04-15
- FDA classified
- 2022-05-05
- Posted by FDA
- 2022-05-11
- Terminated
- 2023-11-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0853-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.