Class II · Moderate risk
Unisom
CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
CORRECTDOSE Children's ALLERGY RELIEF
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL) packaged in 12- 5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-302-05 UPC 8 60003 67144 3
Affected NDC
62320-0302-05
Compare with the code on your package — it is the most precise check available.
Drug: Diphenhydramine Category: Allergy & Cold Medication
- Recalling firm
- Plastikon Healthcare LLC
- NDC code
- 62320-302-05
- Origin
- KS, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1492-2022 · 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 Diphenhydramine recalls
See all
Class II · Moderate risk
Unisom
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
Diphenhydramine HCl 50 mg
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III · Low risk
Diphenhydramine HCl 25 mg
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III · Low risk
Diphenhydramine HCl 25 mg
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Other recalls by Plastikon Healthcare LLC
All 2022 recalls
Class II · Moderate risk
CORRECTDOSE Children's COUGH & CHEST CONGESTION DM
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
CORRECTDOSE Children's PAIN RELIEF & Fever Reducer
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
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