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FDAMarch 17, 2023drug

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

The hazard

Out of specification (OOS) for Spectroscopic Identification test by IR.

What to do

FDA enforcement status: Ongoing

Brands named

ascend laboratoriesascend

Recall history

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

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