FDA recall D-0392-2021

Product

Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013. INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054, NDC 67877-446-30.

Reason for recall

Presence of Foreign Tablet/Capsule

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2021-04-29

Report date

2021-06-02

Termination date

2023-02-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0392-2021