Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each…
Reason Lack of Assurance of Sterility
Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%)…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
What was recalled
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
- Recalling firm
- Parker Laboratories, Inc.
- NDC code
- 30775-052-03
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1091-2023
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Menthol recalls
See all
Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ…
Reason Lack of Assurance of Sterility
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.