Lupin Recalls Tri-Lo-Marzia Tablets Due to Blend Uniformity Deviations
Lupin Pharmaceuticals is recalling specific lots of Tri-Lo-Marzia oral contraceptives due to out-of-specification test results found during a retrospective review of blend uniformity data.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a manufacturing deviation (blend uniformity) without reported injuries.
Plain-English summary
Lupin Pharmaceuticals, Inc. is recalling 34,080 boxes of Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP). The affected product is distributed nationwide in the US and is identified by Lot # L800498 with an expiration date of February 2020. The product is available in 3 x 28's wallets/cartons and is prescription-only.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, an out-of-specification test result was observed during a retrospective review of blend uniformity test data. This indicates that the uniformity of the active ingredients in the tablets may not have met the required standards during the manufacturing process.
Consumers and healthcare providers with this specific lot of Tri-Lo-Marzia should stop using it and contact their healthcare provider or pharmacist for guidance on alternative contraception. The recall is classified as Class III by the FDA, indicating that the product is not likely to cause adverse health consequences.
The recalled product
- 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…
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Oral Contraceptive
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # L800498
- exp. date February 2020
Distribution
Distributed nationwide across the United States.
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