CLASS II Drug recall · Reported 30 Aug 2023 · FDA Enforcement Report
Helix Tri-Active Therapy Cream (Camphor 2%, Menthol recalled
Parker Laboratories is recalling Helix Tri-Active Therapy Cream (Camphor 2%, Menthol 4%, Methyl salicylate 5%), distributed nationwide in the US. The recall was initiated on 2 Aug 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1091-2023
- FDA event ID
- 92786
- Recalling firm
- Parker Laboratories, Fairfield, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Aug 2023
- FDA classified
- 18 Aug 2023
- Reported
- 30 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 2 Aug 2023 | Recall initiated by company | |
| 18 Aug 2023 | Classified by FDA | +16 days |
| 30 Aug 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%), packaged in a) 3 fl. oz. roll-on (NDC 30775-052-03) and b) 4 fl. oz. tube (NDC 30775-052-04) Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004
Where it was distributed
Nationwide within the United States, Singapore, Korea and Hong Kong
Questions about this recall
Is Helix Tri-Active Therapy Cream (Camphor 2%, Menthol 4%, Methyl salicylate 5%) recalled?
Yes. Parker Laboratories recalled Helix Tri-Active Therapy Cream (Camphor 2%, Menthol 4%, Methyl salicylate 5%) on 2 Aug 2023. The recall is Class II and its status is Terminated. Recall number D-1091-2023.
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot #: a) A1221010, Exp. Date 12/9/2023, b) A1221011, Exp date 12/9/2023
Where was it sold?
Nationwide within the United States, Singapore, Korea and Hong Kong
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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