Oral Contraceptive Tablets Recalled for Failed Dissolution Specifications
Teva Pharmaceuticals is recalling TRI-LO-SPRINTEC oral contraceptive tablets nationwide due to failed dissolution specifications affecting 92,676 cartons.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA classified this as a Class II recall. No illnesses or injuries have been reported. However, failed dissolution specifications on an oral contraceptive represent a risk-of-harm product where injury has not yet been reported, due to potential effects on drug absorption.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling TRI-LO-SPRINTEC (norgestimate and ethinyl estradiol), an oral contraceptive, nationwide. The recall affects 92,676 cartons of tablets distributed throughout the United States.
The affected lots are: Lot 100039678 with expiration 04/31/2024, Lot 100038111 with expiration 07/31/2024, and Lot 100042277 with expiration 07/31/2024. These tablets failed to meet dissolution specifications—a manufacturing standard that ensures the tablet dissolves properly in the digestive system to allow absorption of the medication.
Consumers who have taken medication from the affected lots should contact their healthcare provider. Patients should not discontinue use without medical guidance. Healthcare providers can determine whether replacement medication is needed and advise on appropriate precautions.
No illnesses or injuries have been reported in connection with this recall to date.
The recalled product
- Product
- TRI-LO-SPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL)
- Brand
- TRI-LO-SPRINTEC
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Category
- Drug — Oral Contraceptive
- Hazard
- dissolution-failure
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 (5)
- Lot # 100039678
- Exp 04/31/2024
- 100038111
- 100042277
- Exp 07/31/2024
Distribution
Distributed nationwide across the United States.
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