Laavo Clean, S.A. de C.V.

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 product contained an average of 0.15% w/v BZK, or 115% of the label claim (United States Pharmacopeia (USP) Limits: NLT 93.0% and NMT 107.0%).

Passage 2

FDA laboratory testing of two batches of this product detained at the border found that the drug products contained an average of 0.15% and 0.12% w/v BZK, or 92.7% of the label claim, respectively (USP Limits: NLT 93.0% and NMT 107.0%).