Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Helix Pain Relieving Cream
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
Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 30775-051-01), b) 3 fl. oz. roll-on (NDC 30775-051-03), c) 4 fl. oz. tubes (NDC 30775-051-04), d) 12 fl oz pump bottles (NDC 30775-051-12), e) 32 fl. oz. pump bottles (NDC 30775-051-32), f) 1 U.S. gallon with pump (NDC 30775-051-50), g) Starter Kit (NDC 30775-051-95), Parker Laboratories, Inc. 286 Eldridge Road Fairfield, NJ 07004
Affected NDCs
30775-0051-01
30775-0051-03
30775-0051-04
30775-0051-12
30775-0051-32
30775-0051-50
30775-0051-95
Compare with the code on your package — it is the most precise check available.
Drug: Menthol
- Recalling firm
- Parker Laboratories, Inc.
- NDC code
- 30775-051-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1090-2023 · 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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