Drug recall D-0539-2023

Class II Ongoing reported Apr 26, 2023

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

Reason for recall

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

Lots and codes

Lot #22143120, Exp. Date: June 2024

Recall details

Recalling firm
Ascend Laboratories, LLC, Parsippany, NJ
Quantity
135 bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
March 17, 2023

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