PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 30, 2023 Initiated: August 2, 2023 #D-1093-2023

Product Description

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

Reason for Recall

CGMP Deviations

Details

Recalling Firm
Parker Laboratories, Inc.
Units Affected
50
Distribution
Nationwide within the United States, Singapore, Korea and Hong Kong
Location
Fairfield, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Parker Laboratories, Inc.. Units affected: 50.
Why was this product recalled?
CGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on August 30, 2023. Severity: Moderate. Recall number: D-1093-2023.