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FDANovember 14, 2018drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Presence of Foreign Substance; metal shard found in tablet

What to do

FDA enforcement status: Terminated

Brands named

ascend laboratoriesascend

UPCs

367877248011

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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