Why it was recalled
CGMP Deviations
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: a) A1221010, Exp. Date 12/9/2023, b) A1221011, Exp date 12/9/2023
Where it was sold
Nationwide within the United States, Singapore, Korea and Hong Kong
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1091-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 2, 2023
- FDA report date
- Aug 30, 2023
- Quantity
- 8
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Parker Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-1091-2023, exactly as published.
Show all FDA fields
- City
- Fairfield
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 92786
- Address
- 286 Eldridge Rd
- Code information
- Lot #: a) A1221010, Exp. Date 12/9/2023, b) A1221011, Exp date 12/9/2023
- Postal code
- 07004-2509
- Report date
- Aug 30, 2023
- Product type
- Drugs
- Recall number
- D-1091-2023
- Classification
- Class II
- Recalling firm
- Parker Laboratories, Inc.
- Product quantity
- 8
- Termination date
- Jun 3, 2024
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States, Singapore, Korea and Hong Kong
- Recall initiation date
- Aug 2, 2023
- Initial firm notification
- Center classification date
- Aug 18, 2023