Donepezil Hydrochloride Tablets Recalled Due to Storage Temperature Deviations
Cardinal Healthcare is recalling Donepezil Hydrochloride 5 mg tablets (Batch 17605) distributed nationwide because they were exposed to temperatures outside labeled storage conditions, which could affect drug stability.
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 FDA Class II recall involves risk of compromised drug efficacy due to storage temperature deviations. No illnesses or injuries have been reported, aligning with the rubric criterion for risk-of-harm products where injury has not yet been documented.
Plain-English summary
Cardinal Healthcare is recalling Donepezil Hydrochloride 5 mg tablets, a prescription medication distributed by Solco Healthcare U.S. LLC. Batch 17605 was distributed nationwide in the United States.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The recalled tablets were exposed to temperatures outside the product's labeled storage conditions.
Patients currently taking this medication should consult their healthcare provider or pharmacist regarding the recall. The affected product is identified by NDC 43547-275-09 and related package numbers.
The recalled product
- Product
- DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE)
- Brand
- DONEPEZIL HYDROCHLORIDE
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug — Prescription Medication
- Hazard
- temperature-deviation
- efficacy-risk
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 (1)
- Batch 17605
UPCs (2)
- 0343547276034
- 0343547275037
Distribution
Distributed nationwide across the United States.
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