April 2021 FDA Recall Olmesartan Medoxomil by Ascend Laboratories Llc
D-0392-2021 - Presence of Foreign Tablet/Capsule
This Class III drug recall was voluntarily initiated by Ascend Laboratories Llc on April 29, 2021 for the product Olmesartan Medoxomil. The FDA reported the reason for recall as presence of foreign tablet/capsule. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0392-2021
Presence of Foreign Tablet/Capsule
04-29-2021
06-02-2021
34296 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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
02-17-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013. INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054, NDC 67877-446-30.
Batch or Lot Expiration Information
Batch# Batch No. 20122548, Exp Date: Aug. 2022
