Fluphenazine HCl Elixir
Failed Stability Specifications
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Microbial contamination of sterile products
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by: Zap Inc., 350 Joe Frank Harris Parkway, SE, Emerson, GA 30137, NDC 66949-133-85.
Compare with the code on your package — it is the most precise check available.
Drug: Alcohol
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Zep Alcohol Sanitizer Ethanol NDC 66949-0133 |
ALCOHOL 70 mL/100mL | Liquid Topical |
Zep Inc. | OTC |
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.
Failed Stability Specifications
Failed Stability Specifications
Failed Stability Specifications
Failed Stability Specifications
Failed Stability Specifications
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Microbial Contamination of Non-Sterile Products
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