Class II · Moderate risk
Fungal Fusion ERADICATION Solution
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
MakeSense PHARMA ANTIFUNGAL CREAM 1 oz. Miconazole Nitrate 2%
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
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
MakeSense PHARMA ANTIFUNGAL CREAM 1 oz. Miconazole Nitrate 2%, 1 oz. (28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-208-28
Affected NDC
69020-0208-28
Compare with the code on your package — it is the most precise check available.
Drug: Miconazole
- Recalling firm
- Cherry Hill Sales Co.
- NDC code
- 69020-208-28
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0486-2017 · 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 Miconazole recalls
See all
Class II · Moderate risk
DermaFungal
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II · Moderate risk
Medline Remedy Clinical TREAT Antifungal Cream
Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.
Class I · High risk
TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder
Chemical Contamination; presence of benzene.
Class II · Moderate risk
Clinical TREAT Antifungal Powder
CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate.
Other recalls by Cherry Hill Sales Co.
All 2017 recalls
Class II · Moderate risk
MakeSense PHARMA ANTIFUNGAL CREAM Clotrimazole 1%
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
MakeSense PHARMA FIRST AID CREAM Lidocaine HCL 0.5%
CGMP Deviations
Class II · Moderate risk
MakeSense PHARMA
CGMP Deviations
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