Reported Jan 22, 2020 · Terminated
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…
Lupin Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lupin Pharmaceuticals Inc. · Harborplace Tower · Baltimore, MD · 21202-6174
Is this the product you have?
- 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 byLupin Limited, Pithampur, (M.P.)- 454775, India. NDC 68180-837-13 (3x28 carton ) NDC 68180-837-11 (28 tablet wallet)
- Lot codes and dates
Lot # L800498exp. date February 2020
- Amount recalled
- 34,080 boxes (3 wallets per carton, 80 cartons per box)
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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