FDA-Drug2018-12-05Class II
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
Ascend Laboratories LLC
Hazard
Presence of Foreign Substance; metal shard found in tablet
Sold states
Nationwide
Affected count
N/A
Manufactured in
339 Jefferson Rd Ste 101, N/A, Parsippany, NJ, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0287-2019Don't want to check this manually?
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