FDA Drug recall D-0790-2020
Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg
- FDA Drug
- Class III
- terminated
- Published 2020-01-22
On 2020-01-22 the FDA classified a Class III recall of Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg by Lupin Pharmaceuticals, citing CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0790-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-01-10 |
| Published | 2020-01-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
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
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Identifiers
| code_info | Lot # L800498, exp. date February 2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0790-2020%22
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