FDA-Drug2020-01-22Class III
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)
Lupin Pharmaceuticals Inc.
Hazard
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Sold states
Distributed nationwide in the US
Affected count
34,080 boxes (3 wallets per carton, 80 cartons per box)
Manufactured in
Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, MD, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0790-2020Don't want to check this manually?
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