FDA-Drug2019-04-17Class III
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
Hazard
Failed Impurities/Degradation Specifications; 18 month long term stability study.
Sold states
Product was distributed to 6 wholesalers/ drug chains and 2 mail order pharmacies that may have further distribute the product throughout the United States.
Affected count
12,504 bottles
Manufactured in
111 S Calvert St Fl 21ST, N/A, Baltimore, MD, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1121-2019More Lupin Pharmaceuticals Inc. recalls
- FDA-Drug2026-07-08prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: Lupin Limited, Pithampur (M.P) 454 775, INDIA
- FDA-Drug2026-07-08Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-311-01
- FDA-Drug2026-05-27Lupin Liraglutide Injection recalled for particulate matter in cartridges
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