April 2019 FDA Recall Telmisartan And Amlodipine by Lupin Pharmaceuticals Inc.
D-1121-2019 - Failed Impurities/Degradation Specifications; 18 month long term stability study.
This Class III drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on April 1, 2019 for the product Telmisartan And Amlodipine. The FDA reported the reason for recall as failed impurities/degradation specifications; 18 month long term stability study.. The product was distributed in Product was distributed to 6 wholesalers/ drug chains and 2 mail order pharmacies that may have further distribute the product throughout the United States. and the recall is currently terminated.
Recall Number: D-1121-2019
Failed Impurities/Degradation Specifications; 18 month long term stability study.
04-01-2019
04-17-2019
12,504 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.
Lupin Pharmaceuticals 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.
Product was distributed to 6 wholesalers/ drug chains and 2 mail order pharmacies that may have further distribute the product throughout the United States.
07-01-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# G705843 Exp. date April, 2019 G707763 Exp. date August, 2019 G800434 Exp. date November, 2019
