FDA-Drug2023-04-26Class II
Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC#: 67877-434-05
Ascend Laboratories, LLC
Hazard
Out of specification (OOS) for Spectroscopic Identification test by IR.
Sold states
Nationwide in the USA
Affected count
135 bottles
Manufactured in
339 Jefferson Rd Ste 101, N/A, Parsippany, NJ, United States
Products
Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC#: 67877-434-05
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0539-2023Don't want to check this manually?
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