November 2018 FDA Recall Amlodipine And Olmesartan Medoxomil by Aurobindo Pharma Usa Inc.
D-0289-2019 - Discoloration
This Class III drug recall was voluntarily initiated by Aurobindo Pharma Usa Inc. on November 30, 2018 for the product Amlodipine And Olmesartan Medoxomil. The FDA reported the reason for recall as discoloration. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0289-2019
Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).
11-30-2018
12-12-2018
4464 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.
Aurobindo Pharma USA Inc.
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.
U.S.A. Nationwide
02-01-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 0852 Made in India, NDC 65862-855-30
Batch or Lot Expiration Information
Lot# : OWSA18002-A, Exp 7/2020
