FDAClass IIApril 26, 2023

Aripiprazole Tablets recall

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

Why was Aripiprazole Tablets recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #22143120, Exp. Date: June 2024

Product
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
Recalling firm
Ascend Laboratories, LLC
Quantity
135 bottles
Distribution
Nationwide in the USA
Recall date
April 26, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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