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Class II · Moderate risk Terminated Initiated Aug 18, 2020 (6 years ago)

Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

cGMP Deviations

Cause type: cGMP deviation

Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.

What was recalled

Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Grupo Yacana Mexico SAS de CV Ave. Alfonso reyes 714 Col. Contry La Silla, Monterrey, Nuevo Leon, Mexico Tel. +52 812473-8453, NDC # 76592-002-04, UPC 6 03765 37699 3

Affected NDC 76592-0002-04

Compare with the code on your package — it is the most precise check available.

Drug: Alcohol

Recalling firm
Grupo Yacana Mexico Sas De Cv
NDC code
76592-002-04
Origin
N/A, Mexico
Initiated by
Voluntary: Firm initiated
Company announcement
Aug 18, 2020 · FDA notice with lot numbers
FDA recall number
D-1590-2020 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Alcohol recalls

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Other recalls by Grupo Yacana Mexico Sas De Cv

All 2020 recalls