Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA
Summary
The FDA issued a Class II for Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufact by Ascend Laboratories, LLC. Reason: Out of specification (OOS) for Spectroscopic Identification test by IR..
Details
Source
Drug Recall
External ID
D-0539-2023
Action Date
2023-04-26
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot #22143120, Exp. Date: June 2024
Quantity Affected: 135 bottles
Reason for Recall
Out of specification (OOS) for Spectroscopic Identification test by IR.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-17
Company
Parsippany, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 28 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Ascend Laboratories, LLC has 30 FDA actions in our database, including 30 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ascend Laboratories, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ascend Laboratories, LLC have FDA actions?
Ascend Laboratories, LLC has 30 FDA actions in our database, including 30 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0539-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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