Sunitinib Malate Capsules Recalled Due to Excess Moisture Content
Teva Pharmaceuticals is recalling 180 bottles of Sunitinib Malate Capsules due to moisture content exceeding approved specifications. The affected lot (100037220) expires 10/2024.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 Class II recall without reported illnesses or injuries. Excess moisture in prescription drug specifications represents a potential risk to product integrity and efficacy for a serious cancer medication, but no actual adverse events have been documented. Per the rubric, this constitutes a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Teva Pharmaceuticals USA Inc is recalling 180 bottles of Sunitinib Malate Capsules, 12.5 mg, due to water (moisture) content above the approved product specifications. The affected lot is 100037220 (expires 10/2024).
The recalled product was distributed nationwide through three wholesalers and distributors in the United States. Patients taking this medication, along with healthcare providers and pharmacies, should contact Teva Pharmaceuticals or their pharmaceutical supplier for instructions regarding product from this lot.
The recalled product
- Product
- SUNITINIB MALATE (SUNITINIB MALATE)
- Brand
- SUNITINIB MALATE
- Manufacturer
- Teva Pharmaceuticals USA Inc
- Category
- Drug — Prescription / Oncology
- Affected units
- 180
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 # 100037220
- Exp 10/2024
Distribution
Distributed nationwide across the United States.
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