April 2019 FDA Recall Drug by Avkare Inc. (D-1122-2019 - Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer))

This Class III drug recall was voluntarily initiated by Avkare Inc. on April 3, 2019 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications; 18 month long term stability study (manufacturer). The product was distributed in AZ, CO and the recall is currently terminated.

Recall Number: D-1122-2019

Reason for Recall
Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
Initiated
04-03-2019
Reported
04-17-2019
Quantity
397 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82564
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AVKARE Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
AZ, CO
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-07-2020
Product Description About Product Description
Full technical description of the product.
Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30

Batch or Lot Expiration Information

Lot# Lots: 201916 Exp. 08/2019; 20092 Exp. 08/2019