FDAFDA · Food and drugs·Recall number D-1121-2019
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
Published April 17, 2019 · Recall initiated: April 1, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications; 18 month long term stability study.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TELMISARTAN AND AMLODIPINE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- Product was distributed to 6 wholesalers/ drug chains and 2 mail order pharmacies that may have further distribute the product throughout the United States.
- UPC
- 0368180196068
- Lot
- G705843 Exp. date April, 2019 G707763 Exp. date August, 2019 G800434 Exp. date November, 2019
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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