FDA recall D-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.

Reason for recall

Failed Dissolution Specifications

Distribution

OH

Key facts

Status

Terminated

Initiation date

2022-04-15

Report date

2022-05-11

Termination date

2023-11-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0853-2022