January 2022 FDA Recall Metoprolol Succinate by Ascend Laboratories, Llc
D-0393-2022 - Failed Dissolution Specifications.
This Class II drug recall was voluntarily initiated by Ascend Laboratories, Llc on January 12, 2022 for the product Metoprolol Succinate. The FDA reported the reason for recall as failed dissolution specifications.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0393-2022
Failed Dissolution Specifications.
01-12-2022
02-02-2022
9216 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.
Terminated
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
05-31-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, 07054, NDC 67877-590-01.
Batch or Lot Expiration Information
Lot# : 21143093, Exp. March 2023
