Tri-Lo-Marzia recalled over manufacturing violations

Recall date

January 10, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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…

Recall number

D-0790-2020

FDA classification

Class III

Brand / firm

Lupin Pharmaceuticals Inc.

Sold / distributed

Distributed nationwide in the US

Why it was recalled

CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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)