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
Diphenhydramine 50 mg/ml Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
What was recalled
Diphenhydramine 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
- Recalling firm
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-723-2013
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.
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