March 2023 FDA Recall Aripiprazole by Ascend Laboratories, Llc (D-0539-2023 - Out of specification (OOS) for Spectroscopic Identification test by IR.)
This Class II drug recall was voluntarily initiated by Ascend Laboratories, Llc on March 17, 2023 for the product Aripiprazole. The FDA reported the reason for recall as out of specification (oos) for spectroscopic identification test by ir.. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0539-2023
Out of specification (OOS) for Spectroscopic Identification test by IR.
03-17-2023
04-26-2023
135 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Ascend Laboratories, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# 22143120, Exp. Date: June 2024
