Ascend Laboratories LLC recalls Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013,
Recalled December 5, 2018 · FDA recall D-0287-2019 · Ascend Laboratories
Hazard
Presence of Foreign Substance; metal shard found in tablet · FDA Class II
Units
N/A
Sold at
Nationwide
Description
Presence of Foreign Substance; metal shard found in tablet
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
Manufacturer(s)
Ascend Laboratories LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →