Recall: D-0287-2019

Class II - Potentially Harmful

Class IIClassification

2018-11-14Initiated

TerminatedStatus

Ascend Laboratories LLCFirm

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

Presence of Foreign Substance; metal shard found in tablet

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.