Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025...
FDA Recall #D-0790-2020 — Class III — January 10, 2020
Product Description
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)
Reason for Recall
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
34,080 boxes (3 wallets per carton, 80 cartons per box)
Distribution
Distributed nationwide in the US
Code Information
Lot # L800498, exp. date February 2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated