Lupin Pharmaceuticals Inc. recalls Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025
Recalled January 22, 2020 · FDA recall D-0790-2020 · Lupin Pharmaceuticals
Hazard
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data. · FDA Class III
Units
34,080 boxes (3 wallets per carton, 80 cartons per box)
Sold at
Distributed nationwide in the US
Description
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Product
Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack size - 3 x 28's wallets/carton, Rx Only, Distributed by Lupin Pharmaceuticals, Inc, Baltimore MD 21202, Manufactured by: Lupin Limited, Pithampur, (M.P.)- 454775, India. NDC 68180-837-13 (3x28 carton ) NDC 68180-837-11 (28 tablet wallet)
Manufacturer(s)
Lupin Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →