PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 3, 2022 Initiated: July 13, 2022 #D-1287-2022

Product Description

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

Reason for Recall

FAILED DISSOLUTION SPECIFICATIONS

Details

Units Affected
2,892 cartons
Distribution
Nationwide in the USA
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 2,892 cartons.
Why was this product recalled?
FAILED DISSOLUTION SPECIFICATIONS
Which agency issued this recall?
This recall was issued by the FDA Drug on August 3, 2022. Severity: Moderate. Recall number: D-1287-2022.