FDA warning letter · Drugs

Frozen Wheels, LLC

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

FDA laboratory testing of a batch of this product detained at the border found that the drug you attempted to import contained an average of 0% ethyl alcohol and 54% of methanol v/v.

Passage 2

FDA laboratory testing of a batch of this product detained at the border found that the drug you attempted to import contained an average of 9.6% ethyl alcohol and an average of 58% of methanol v/v.

Passage 3

FDA laboratory testing of this product detained at the border found that the drug you attempted to import contained < 0.25% of ethyl alcohol and instead was comprised of 63% isopropanol.