Recalls / Class II
Class IID-1091-2023
Product
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
- Affected lot / code info
- Lot #: a) A1221010, Exp. Date 12/9/2023, b) A1221011, Exp date 12/9/2023
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Parker Laboratories, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 286 Eldridge Rd, N/A, Fairfield, New Jersey 07004-2509
Distribution
- Quantity
- 8
- Distribution pattern
- Nationwide within the United States, Singapore, Korea and Hong Kong
Timeline
- Recall initiated
- 2023-08-02
- FDA classified
- 2023-08-18
- Posted by FDA
- 2023-08-30
- Terminated
- 2024-06-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1091-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.