Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada. recall

Why it was recalled

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

Details

Product

Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.

Recalling company

Keystone Industries

Classification

Class II

Status

Terminated

Type

Voluntary: Firm initiated

Distribution

Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.

Initiated

Nov 14, 2024

FDA report date

Dec 25, 2024