Class II · Moderate risk Ongoing
Unisom
Reason CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
Pure-Aid Allergy Relief
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredient as Chlorpheniramine rather than Diphenhydramine
What was recalled
Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Exclusively distributed by: Kareway Products Inc., Compton, CA --- UPC 8 56023 00158 2
- Recalling firm
- Kareway Product Inc
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-620-2013
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Diphenhydramine recalls
See all
Class II · Moderate risk Ongoing
Unisom
Reason CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Class III · Low risk Ongoing
Diphenhydramine HCl 50 mg
Reason Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III · Low risk Ongoing
Diphenhydramine HCl 25 mg
Reason Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III · Low risk Ongoing
Diphenhydramine HCl 25 mg
Reason Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.