Tretinoin Capsules Recalled Nationwide for Failed Dissolution Specifications
Teva Pharmaceuticals is recalling Tretinoin Capsules (10 mg) nationwide due to failed dissolution specifications that may affect medication effectiveness. Patients should contact their pharmacist or doctor to confirm if their prescription is affected.
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: This is an FDA Class II recall for a prescription medication due to failed dissolution specifications, which could affect drug bioavailability and treatment effectiveness. No illnesses or injuries have been reported, but the quality defect poses a risk to proper medication treatment.
Plain-English summary
Teva Pharmaceuticals USA Inc. is recalling Tretinoin Capsules, 10 mg, due to failed dissolution specifications. The capsules may not dissolve properly in the body, which could affect how much medication is absorbed and the effectiveness of treatment.
The recall affects 4,941 bottles distributed nationwide in the United States. The affected lots are: Lot #100022971 (expiration 08/2022), Lot #100022972 (expiration 05/2023), and Lot #100028920 (expiration 09/2023). The product is identified by NDC 0555-0808-02 and comes in bottles of 100 capsules.
Patients currently taking this medication should contact their pharmacist or doctor to confirm whether their prescription is affected by this recall. Do not stop taking the medication without consulting your healthcare provider. Your doctor or pharmacist may recommend obtaining a replacement supply or switching to an alternative medication.
For more information about this recall, contact Teva Pharmaceuticals USA Inc. or visit the FDA's drug recalls webpage.
The recalled product
- Product
- Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.
- Manufacturer
- Teva Pharmaceuticals USA Inc
- Category
- Drug
- 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 (6)
- Lot #s: 100022971
- Exp. 08/2022
- 100022972
- Exp. 05/2023
- 100028920
- Exp. 09/2023
Distribution
Distributed nationwide across the United States.
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