The Recall Desk
ModerateFDA (Drugs)·D-1091-2023·Announced 2023-08-30

Helix Tri-Active Therapy Cream Recalled for Manufacturing Quality Deviations

Parker Laboratories is voluntarily recalling Helix Tri-Active Therapy Cream due to manufacturing quality control deviations. The recall affects products with lot numbers A1221010 and A1221011, expiring December 9, 2023, distributed in the United States, Singapore, Korea, and Hong Kong.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II voluntary firm-initiated recall due to manufacturing quality control deviations. No specific health hazard is identified. Fits the rubric for Score 2 as a voluntary precautionary recall.

Plain-English summary

Helix Tri-Active Therapy Cream, manufactured by Parker Laboratories, Inc., is being recalled due to manufacturing quality control deviations. The product is a topical cream containing Camphor 3.2%, Menthol 7.4%, and Methyl salicylate 12.5%, packaged as a 3 fl. oz. roll-on or 4 fl. oz. tube.

The FDA classified this as a Class II recall because of Current Good Manufacturing Practice (CGMP) deviations. Parker Laboratories voluntarily initiated the recall on August 2, 2023.

The affected product was distributed nationwide in the United States, Singapore, Korea, and Hong Kong. Lot numbers A1221010 and A1221011, both expiring December 9, 2023, are included in the recall. The FDA terminated this recall on June 3, 2024.

If you have purchased this product, discontinue use and dispose of it safely. For more information, contact Parker Laboratories, Inc. at 286 Eldridge Road, Fairfield, NJ 07004.

The recalled product

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
Manufacturer
Parker Laboratories, Inc.
Category
Drug — Topical / Therapy Cream
Hazard
  • cgmp-deviation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot #: a) A1221010
  • Exp. Date 12/9/2023
  • b) A1221011
  • Exp date 12/9/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category