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Recall Observatory FDA recall evidence

Drug product

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

D-0385-2026

February 18, 2026

Class II

Product summary

Firm
HTO Nevada Inc. dba Kirkman
Event
Event 98494
Status
Ongoing
Classification
Class II
Quantity
27,380 bottles.
Official record key
drug-enforcement:D-0385-2026

Official wording

Reason: Stability Data Does Not Support Expiry Date.

Code information: 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.

Distribution pattern: Nationwide within the U.S

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Stability Data Does Not Support Expiry