FDA Recall Telmisartan And Amlodipine

The most recent Recall Enforcement Report that covers this product was initiated on April 1st, 2019 and classified as a Class III recall due to failed impurities/degradation specifications; 18 month long term stability study. This recall is currently terminated, and the associated recall number is recall number is D-1121-2019. It pertains to Telmisartan And Amlodipine identified by 68180-196 as of 07-01-2020 .

Recall Number D-1121-2019

Event ID

82528 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).

Recall Number

D-1121-2019 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).

Recall Classification

Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".

Distribution Pattern

Product was distributed to 6 wholesalers/ drug chains and 2 mail order pharmacies that may have further distribute the product throughout the United States. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.

Product Description

Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by : Lupin Limited, Goa, INDIA -- NDC 68180-198-06

Reason For Recall

Failed Impurities/Degradation Specifications; 18 month long term stability study. What is the Reason for Recall?
Information describing how the product is defective.

Product Quantity

12,504 bottles Product Quantity
The amount of product subject to recall.

Voluntary Mandated

Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.

Report Date

04-17-2019

Recall Initiation Date

04-01-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.

Termination Date

07-01-2020 What is the Date Terminated?
The date that FDA terminated the recall.

Initial Firm Notification

Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.

Product Type

Drugs

Recalling Firm

Lupin Pharmaceuticals Inc.

Code Info/dt>

G705843 Exp. date April, 2019 G707763 Exp. date August, 2019 G800434 Exp. date November, 2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.

Recalled NDC Packages

68180-196-06; 68180-196-09; 68180-196-12; 68180-197-06; 68180-197-09; 68180-197-12; 68180-197-07; 68180-198-06; 68180-198-09; 68180-198-12; 68180-199-06; 68180-199-09; 68180-199-12

Status

Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

View Recall Report

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.