Drug & medication recalls Moderate risk

Techni-Care Chloroxylenold 3% recalled over manufacturing violations

Recall date
January 10, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Consolidated Chemical, Inc recalls Techni-Care Chloroxylenold 3%, [4 fl oz /118 mL or 8 fl oz/236 mL] per bottle, Care-Tech Laboratories, Inc., Saint Loui…
Recall number
D-0325-2023
FDA classification
Class II
Brand / firm
Consolidated Chemical, Inc
Sold / distributed
Nationwide in the USA

Why it was recalled

CGMP Deviations: initiated due to violations of CGMP manufacturing practices

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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