Class II · Moderate risk
Donepezil HCl Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Donepezil HCl Tablets (Donepezil Hydrochloride)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
Donepezil HCl Tablets, 5 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-275-09
Affected NDC
43547-0275-09
Compare with the code on your package — it is the most precise check available.
Drug: Donepezil
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| donepezil hydrochloride NDC 43547-0275 |
5 mg/1 | Tablet, Film Coated Oral |
Solco Healthcare US, LLC | Rx |
- Recalling firm
- Cardinal Healthcare
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0177-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Donepezil recalls
See all
Class III · Low risk
Donepezil HCL Tablets
Subpotent
Class II · Moderate risk
Namzaric (memantine HCl extended release and donepezil HCl)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk
Donepezil HCl tablets
Supotent: Out of Specification result for assay test during routine stability testing.
Class III · Low risk
Donepezil Hydrochloride Tablets
Subpotent Drug: out of specification results for assay test.
Other recalls by Cardinal Healthcare
All 2022 recalls
Class II · Moderate risk
Inhub Wixela
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Warfarin Sodium Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Warfarin Sodium Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Triamterene and Hydrochlorothiazide Capsules
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
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