Reported Apr 17, 2019 · Terminated
Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals,…
Lupin Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lupin Pharmaceuticals Inc. · 111 S Calvert St Fl 21ST · Baltimore, MD · 21202-6174
Is this the product you have?
- Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only
- Manufactured forLupin Pharmaceuticals, Inc., Baltimore, MD
- Manufactured byLupin Limited, Goa, INDIA -- NDC 68180-198-06
- Lot codes and dates
G705843 Exp. date April2019 G707763 Exp. date August2019 G800434 Exp. date November2019
- Amount recalled
- 12,504 bottles
Why it was recalled
Failed Impurities/Degradation Specifications; 18 month long term stability study.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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