Ascend Laboratories LLC recalls Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013,…

Recall date

November 14, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0287-2019

FDA classification

Class II

Brand / firm

Ascend Laboratories LLC

Sold / distributed

Nationwide

Why it was recalled

Presence of Foreign Substance; metal shard found in tablet

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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