Lupin Pharmaceuticals Inc. recalls Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable Tablets
Recalled August 7, 2019 · FDA recall D-1565-2019 · Lupin Pharmaceuticals
Hazard
Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study. · FDA Class II
Units
12938 units
Sold at
Nationwide in the USA
Description
Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.
Product
Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable Tablets, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, MD - 21202 Manufactured by: Lupin Limited Pathampur -454775 India. NDC 68180-903-11 (wallet of 28 tablets) NDC 68180-903-13 (carton of 3 wallets)
Manufacturer(s)
Lupin Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →