Sandoz Recalls Syeda Oral Contraceptives for Incorrect Tablet Imprinting
Sandoz is recalling Syeda oral contraceptives because some tablets have the wrong ID imprint. Consumers should stop using the affected lot and contact a healthcare provider.
What this means for you
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 by definition is unlikely to cause adverse health consequences. The issue is a cosmetic labeling error (incorrect imprint) rather than a functional or safety defect.
Plain-English summary
Sandoz Incorporated is recalling 17,188 cartons of Syeda (drospirenone and ethinyl estradiol) combination oral contraceptive tablets. The product is manufactured by Laboratorios Leon Farma S.A. in Spain for Sandoz Inc. in Princeton, New Jersey. The recall is due to a manufacturing error where a portion of the tablets may contain the incorrect debossing (imprint) on one side, showing "U2" instead of the correct "U3".
The affected product consists of 3 x 28 tablet blistercards. The specific lot number is LF01215A with an expiration date of 02/2014. The recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences. The distribution was nationwide.
Consumers who have this specific lot of Syeda should stop using the product and contact their healthcare provider or pharmacist for guidance. They should also contact Sandoz Incorporated for further information or to arrange for a return or replacement.
The recalled product
- Product
- Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blistercards, combination oral contraceptive tablet, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ
- Manufacturer
- Sandoz Incorporated
- Category
- Drug — Oral Contraceptive
- Hazard
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)
- LF01215A
- Exp 02/2014
Distribution
Distributed nationwide across the United States.
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