Drug recall D-0790-2020

Class III Terminated reported Jan 22, 2020

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)

Reason for recall

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

Lots and codes

Lot # L800498, exp. date February 2020

Recall details

Recalling firm
Lupin Pharmaceuticals Inc., Baltimore, MD
Quantity
34,080 boxes (3 wallets per carton, 80 cartons per box)
Distribution
Distributed nationwide in the US
Type
Voluntary: Firm initiated
Recall initiated
January 10, 2020
Terminated
June 3, 2021

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