← FDA ENFORCEMENT
D-1090-2023Class II

Parker Laboratories, Inc.

Recalling firm
Parker Laboratories, Inc.
Product type
Drug
Status
Terminated
Report date
2023-08-30
Distribution
Nationwide within the United States, Singapore, Korea and Hong Kong
Firm state
NJ
Product quantity
250
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

CGMP Deviations

Product description

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 with pump (NDC 30775-051-50), g) Starter Kit (NDC 30775-051-95), Parker Laboratories, Inc. 286 Eldridge Road Fairfield, NJ 07004

Code / lot info

a) J0721010, Exp. Date 6/30/2024; J1022017, Exp. Date 10/27/2025; b) A0521002, Exp. Date 4/29/2024; c) A0322006, Exp. Date 3/2/2025, A0323004, Exp. Date 2/24/2026, A0422005, Exp. Date 3/14/2025, A0521001, Exp. Date 4/29/2024, A0822004, Exp. Date 7/27/2025, d) C0222001, Exp. Date 6/30/2023, C0521003, Exp. Date 4/29/2023, C0822005, Exp. Date 7/27/2024, e)C0721019, Exp. Date 6/30/2024, f) C0521001, Exp. Date 4/29/2024, C0721022, Exp. Date 6/30/2024, C0822006, Exp. Date 7/27/2025, g) C0323006, C0821022, C0922006, Exp. Date 4/29/2024, C1221003, Exp. Date 4/09/2024

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.