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Class III · Lower riskRecall completed

Telmisartan And Amlodipine

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberG705843 Exp. date April, 2019 G707763 Exp. date August, 2019 G800434 Exp. date November, 2019
Where it was soldProduct was distributed to 6 wholesalers/ drug chains and 2 mail order pharmacies that may have further distribute the product throughout the United States.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Impurities/Degradation Specifications; 18 month long term stability study.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byLupin Limited, Goa, INDIA -- foreign manufacturer
Brand nameTELMISARTAN AND AMLODIPINE
Generic nameTELMISARTAN AND AMLODIPINE
Active ingredient(s)AMLODIPINE BESYLATE, TELMISARTAN
Distributed by / forLupin Pharmaceuticals, Inc., Baltimore, MD
NDC68180-198-06
Show the full FDA record
Full product labelTelmisartan 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
Recalling firmLupin Pharmaceuticals Inc.
DistributionProduct was distributed to 6 wholesalers/ drug chains and 2 mail order pharmacies that may have further distribute the product throughout the United States.
Quantity12,504 bottles
Recall initiated2019-04-01
Report date2019-04-17
Recall completed2020-07-01
Recall numberD-1121-2019
ClassificationClass III
FDA statusTerminated
Origin on fileBaltimore MD United States

Related

Amlodipine recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.