FDA recall D-0287-2019

Product

Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 --- NDC 67877-248-01, UPC code: 3 67877-248-01 1

Reason for recall

Presence of Foreign Substance; metal shard found in tablet

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2018-11-14

Report date

2018-12-05

Termination date

2020-03-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0287-2019