The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0066-2019·Announced 2018-10-24

Freeze It Spray Recalled for High Camphor Levels

Product Quest Manufacturing LLC is recalling Freeze It spray cans due to high out-of-specification camphor levels.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric for significant potential health risks.

Plain-English summary

Product Quest Manufacturing LLC is recalling 6,109 cans of FREEZE IT (camphor 0.2% and menthol 3.5%) spray, 118.29 mL (4 fl. oz.) size. The product is distributed by Expedite Products, Inc., in Tampa, FL, and was sold nationwide in the USA. The specific lot number is 170498B, with an expiration date of 02/23/2020, and the UPC is 8 56569 00203 6.

The recall was initiated because the product had high out-of-specification assay results for the camphor ingredient. This is classified as a Class II recall by the FDA, indicating a situation that might cause temporary or medically reversible health problems.

Consumers who have this product should stop using it and check the lot number and expiration date on the can. If the product matches the recalled lot, consumers should contact the distributor or manufacturer for instructions on how to return or dispose of the product.

The recalled product

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.
Manufacturer
Product Quest Manufacturing LLC
Category
Drug — Topical Analgesic
Hazard
Affected units
6,109

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: 170498B
  • Exp. 02/23/2020

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 54 recalled by Product Quest Manufacturing LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 54 products in this recall →

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