Fairfield, NJ, United States
Parker Laboratories, Inc. recalls
4 recalls recorded since 2018, most recently on 22 March 2024. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)2
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 22 March 2024
- Reason
- Product demonstrates low viscosity.
- Distribution
- Worldwide distribution - US Nationwide in the states of CA, CO, FL, GA, IL, MD, MI, MN, NC, NE, NY, OH, PA, SC, & TX. The countries of AU, CA, OM, & SA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1604-2024
- Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.
Ongoing Class II Medical devices
- Recall started
- 22 January 2024
- Reason
- Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60.
- Distribution
- US (Domestic): AZ, CA, FL, NC, NJ, NV, NY, PA, WA, WI. OUS (Foreign): Canada, France and Germany.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1204-2024
- Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.
Terminated Class II Drugs
- Recall started
- 2 August 2023
- Terminated
- 3 June 2024
- Reason
- CGMP Deviations
- Distribution
- Nationwide within the United States, Singapore, Korea and Hong Kong
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1090-2023, D-1091-2023, D-1092-2023, D-1093-2023, D-1089-2023
- 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
- 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 Ro
- 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
- 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, Fairfie
- 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 Ro
Terminated Class II Medical devices
- Recall started
- 13 April 2017
- Terminated
- 26 October 2020
- Reason
- There is a potential for the gel packets to have leaks in the packet seal.
- Distribution
- The products were distributed to the following US states: CA, FL, GA, IA, IL, OH, TN, and VA. The products were distributed to the following foreign countries: Canada, United Kingdom, and Malta.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1777-2018
- Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.