← FDA ENFORCEMENT
D-1093-2023Class 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
50
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

CGMP Deviations

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

Code / lot info

Lot #: a) J1121011, Exp. Date 12/21/2023, b) A0921009, Exp. Date 8/18/2023, c) A0921008, Exp. Date 8/18/2023

Other recalls SPEQ maps to Risk Management & CAPA
2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.
See all Risk Management & CAPA recalls →

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.