FDAFDA · Food and drugs·Recall number D-0790-2020
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)
Published January 22, 2020 · Recall initiated: January 10, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- Distributed nationwide in the US
- Lot
- Lot # L800498, exp. date February 2020
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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