FDA recall, , Moderate risk
Dermal Source Five-Star Vasocaine Spray and Maximum Zone Lidocaine Creams
Stability Data Does Not Support Expiry Date.
Summary by Recall Canary from the FDA notice
What happened
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your bottle affected?
3 products
Match the lot code and NDC listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Five-Star, Vasocaine Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles
- NDC
- 80069-016
- Lot code
- 839CP-0016
- 839CP-0017
- 839CP-0018
- 839CP-0019
- 839CP-0020
- 839CP-0021
- 839CP-0022
- 839CP-0023
- 839CP-0024
Maximum, Zone 1, 4% Lidocaine Cream, 1/2 oz bottles
- NDC
- 80069-014
- Lot code
- 807CP-0003
Maximum, Zone 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles
- NDC
- 80069-015
- Lot code
- 795CP-0005
Recall details
- Company began the recall
- Sold in
Nationwide within the U.S
- Company
- HTO Nevada Inc. dba KirkmanLake Oswego, Oregon
- Hazard
- Quality testing problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98494
- Recall numbers
- D-0385-2026 to D-0387-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
