Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
MakeSense PHARMA Medicated ANTI-ITCH CREAM WITH SOOTHING ALOE VERA AND VITAMIN E
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 Medicated ANTI-ITCH CREAM WITH SOOTHING ALOE VERA AND VITAMIN E, Camphor-1% Menthol-1%, 1oz.(28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-201-28
Affected NDC
69020-0201-28
Compare with the code on your package — it is the most precise check available.
Drug: Menthol
- Recalling firm
- Cherry Hill Sales Co.
- NDC code
- 69020-201-28
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0485-2017 · 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.
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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
MakeSense PHARMA ANTIFUNGAL CREAM 1 oz. Miconazole Nitrate 2%
CGMP Deviations
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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