Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
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: Greensys of North America LLC. 5001 W Military Hwy Ste 100 McAllen, TX USA 78503, NDC# 76562-000-85, UPC 6 64213 64350 0
Drug: Alcohol
- Recalling firm
- Grupo Yacana Mexico Sas De Cv
- NDC code
- 76562-000-85
- Origin
- N/A, Mexico
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1591-2020 · 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.
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Other recalls by Grupo Yacana Mexico Sas De Cv
All 2020 recalls
Class II · Moderate risk
Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz
cGMP Deviations
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