Drug Enforcement D-0325-2023

CGMP Deviations: initiated due to violations of CGMP manufacturing practices

Status

Ongoing

Classification

Class II

Report Date

February 22, 2023

Termination Date

—

Product Information

Product description
Techni-Care Chloroxylenold 3%, [4 fl oz /118 mL or 8 fl oz/236 mL] per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139. NDC 4 oz bottle: 46706-222-01; NDC 8 oz: 46706-222-02
Product quantity
4 oz: 6580 bottles; 8 oz: 1248 bottles
Reason for recall
CGMP Deviations: initiated due to violations of CGMP manufacturing practices
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Consolidated Chemical, Inc
Address
3224 S Kingshighway Blvd, N/A

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

Codes & Dates

Recall number
D-0325-2023
Event ID
91521
Recall initiation date
January 10, 2023
Center classification date
February 15, 2023
Code info
Lots 3217A and 3217B, exp 06/23
More code info
—