Recalls / Class II
Class IID-0385-2026
Product
FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016.
- Affected lot / code info
- 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.
Why it was recalled
Stability Data Does Not Support Expiry Date.
Recalling firm
- Firm
- HTO Nevada Inc. dba Kirkman
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 6400 Rosewood St, N/A, Lake Oswego, Oregon 97035-5392
Distribution
- Quantity
- 27,380 bottles.
- Distribution pattern
- Nationwide within the U.S
Timeline
- Recall initiated
- 2026-02-18
- FDA classified
- 2026-03-05
- Posted by FDA
- 2026-03-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0385-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.