Recalls / Class II
Class IID-0066-2019
Product
FREEZE IT (camphor 0.2% and menthol 3.5%) spray, 118.29 mL (4 fl. oz.) can, Distributed by: Expedite Products, Inc., Tampa, FL 33619 USA, UPC 8 56569 00203 6.
- Affected lot / code info
- Lot: 170498B, Exp. 02/23/2020
Why it was recalled
Superpotent Drug: high out of specification assay results for the camphor ingredient.
Recalling firm
- Firm
- Product Quest Manufacturing LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 330 Carswell Ave, N/A, Daytona Beach, Florida 32117-4416
Distribution
- Quantity
- 6,109 cans
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-08-03
- FDA classified
- 2018-10-16
- Posted by FDA
- 2018-10-24
- Terminated
- 2021-03-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0066-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.