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Health & beauty United States Recall (ongoing)

HTO Nevada Inc. dba Kirkman recalls FIVE-STAR and 2 more products

HTO Nevada Inc. dba Kirkman is recalling FIVE-STAR VASOCAINE Spray (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4 oz bottles (NDC 80069-016), PLUS MAXIMUM ZONE 1 4% Lidocaine Cream, ½ oz (NDC 80069-014) and MAXIMUM ZONE 2 4% Lidocaine Cream (Lidocaine 4% and Epinephrine 0.01%), 1 oz (NDC 80069-015). The recall covers specific lot numbers and expiration dates because stability data does not support the labeled expiry dates. These products were distributed nationwide in the United States.

What's being recalled

FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016.

MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.

MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015.

Recalling firm: HTO Nevada Inc. dba Kirkman, Lake Oswego, OR, United States.

How to identify it

Lot #: 839CP-0016, Exp. Date 03/31/2026; 839CP-0017, Exp. Date 06/30/2026; 839CP-0018, Exp. Date 08/31/2026; 839CP-0019, Exp. Date 10/31/2026; 839CP-0020, Exp. Date 03/31/2027; 839CP-0021, Exp. Date 07/31/2027; 839CP-0022, Exp.Date 11/30/2027; 839CP-0023, Exp. Date 02/29/2028; 839CP-0024, Exp. Date 07/31/2028. Lot #: 807CP-0003, Exp. Date 07/31/2026. Lot #: 795CP-0005, Exp. Date 06/30/2026

The hazard

Stability Data Does Not Support Expiry Date.

What to do

Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.

The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.

Where it was sold

Nationwide within the U.S

The official notice

This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.

Read the official notice (opens in a new tab)

A little guidance

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