Drug Enforcement D-1091-2023

CGMP Deviations

Status

Terminated

Classification

Class II

Report Date

August 30, 2023

Termination Date

June 3, 2024

Product Information

Product description
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 Road, Fairfield, NJ 07004
Product quantity
8
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-1091-2023
Event ID
92786
Recall initiation date
August 2, 2023
Center classification date
August 18, 2023
Code info
Lot #: a) A1221010, Exp. Date 12/9/2023, b) A1221011, Exp date 12/9/2023
More code info
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