The Recall Desk

FDA (Drugs) recall action 92786

Parker Laboratories, Inc. recalled 5 products on 2023-08-30

The FDA (Drugs) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2023-08-30
Critical
0
Units
357

Why these products were recalled

CGMP Deviations

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–5 of 5

  • ModerateFDA (Drugs)··2023-08-30

    FDA Recalls Helix CBD Clinical Cream for Manufacturing Process Violations

    Parker Laboratories is recalling Helix CBD Clinical Cream due to manufacturing process deviations. The FDA Class II recall affects batches distributed nationwide and internationally; consumers should discontinue use and contact the manufacturer.

    Product
    Helix CBD Clinical Cream (Menthol 7.4%), packaged in a)3 gm pouches (NDC30775-054-01), b)2 fl. oz. tubes (NDC 30775-054-02), and c) 4 fl. oz. tubes (NDC 30775-054-04), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2023-08-30

    Helix CBD Therapy Cream Recalled Due to Manufacturing Deviations

    Parker Laboratories voluntarily recalled Helix CBD Therapy Cream due to Current Good Manufacturing Practice deviations. The recall affects specific lot numbers distributed nationwide and internationally.

    Product
    Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-053-01), b) 2 fl. oz. tubes (NDC 30775-053-02), c) 4 fl. oz. tubes (NDC 30775-053-04), Parker Laboratories Inc., Fairfield, NJ, 07004
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2023-08-30

    Drug manufacturer recalls Protex hand sanitizer due to manufacturing quality deviations

    Parker Laboratories is recalling Protex Foaming Hand Sanitizer due to manufacturing quality control deviations. The voluntary recall affects products distributed nationwide and internationally.

    Product
    Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%), packaged in a) 2 fl oz/60 mL Pump bottles (NDC 30775-040-02) and b)18 fl. oz./550 ml Pump Bottles (NDC 30775-040-18), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··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.

    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
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2023-08-30

    Helix Pain Relieving Cream recalled nationwide for manufacturing process violations

    Parker Laboratories is recalling Helix Pain Relieving Cream due to manufacturing process deviations. The voluntary recall affects multiple package sizes distributed nationwide and internationally.

    Product
    Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 30775-051-01), b) 3 fl. oz. roll-on (NDC 30775-051-03), c) 4 fl. oz. tubes (NDC 30775-051-04), d) 12 fl oz pump bottles (NDC 30775-051-12), e) 32 fl. oz. pump bottles (NDC 30775-051-32), f) 1 U.S. gallon wi
    Category
    Distribution
    0 states