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)
Reported: January 22, 2020 Initiated: January 10, 2020 #D-0790-2020
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.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 34,080 boxes (3 wallets per carton, 80 cartons per box)
- Distribution
- Distributed nationwide in the US
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Lupin Pharmaceuticals Inc.. Units affected: 34,080 boxes (3 wallets per carton, 80 cartons per box).
Why was this product recalled? ▼
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 22, 2020. Severity: Low. Recall number: D-0790-2020.
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