Recalls / Class II
Class IID-1287-2022
Product
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, blister barcode 4359856079, NDC 43598-560-78
- Brand name
- Lansoprazole
- Generic name
- Lansoprazole
- Active ingredient
- Lansoprazole
- Route
- Oral
- NDCs
- 43598-561, 43598-560
- FDA application
- ANDA210465
- Affected lot / code info
- Lot T2100514, Exp 01/2023
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, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 2,892 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-07-13
- FDA classified
- 2022-07-22
- Posted by FDA
- 2022-08-03
- Terminated
- 2023-12-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1287-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.