FDA recall D-0737-2022

Product

Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle, (55111-398-90), Rx Only, Manufactured. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India

Reason for recall

Failed Dissolution Specifications; during long term stability testing.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-03-23

Report date

2022-04-06

Termination date

2024-02-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0737-2022