January 2020 FDA Recall Olmesartan Medoxomil by Ascend Laboratories Llc
D-0828-2020 - cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
This Class II drug recall was voluntarily initiated by Ascend Laboratories Llc on January 24, 2020 for the product Olmesartan Medoxomil. The FDA reported the reason for recall as cgmp deviations; olmesartan medoximil tablets 20 mg was released in error with alternate api source prior to filing and approval of prior approval supplement.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0828-2020
cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
01-24-2020
02-12-2020
192 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 U.S.
10-29-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-446-90.
Batch or Lot Expiration Information
Lot# : 19122552, Exp 7/31/2021
