FDA recall D-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

Reason for recall

FAILED DISSOLUTION SPECIFICATIONS

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-07-13

Report date

2022-08-03

Termination date

2023-12-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1287-2022