Drug Enforcement D-1093-2023

CGMP Deviations

Status

Terminated

Classification

Class II

Report Date

August 30, 2023

Termination Date

June 3, 2024

Product Information

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
Product quantity
50
Reason for recall
CGMP Deviations
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Nationwide within the United States, Singapore, Korea and Hong Kong

Location & Firm

Recalling firm
Parker Laboratories, Inc.
Address
286 Eldridge Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-1093-2023
Event ID
92786
Recall initiation date
August 2, 2023
Center classification date
August 18, 2023
Code info
Lot #: a) J1121011, Exp. Date 12/21/2023, b) A0921009, Exp. Date 8/18/2023, c) A0921008, Exp. Date 8/18/2023
More code info
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