Class II · Moderate risk Ongoing
Xylocaine
Reason Presence of Particulate Matter: Hair was found in products
Alprostadil/Lidocaine HCL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
What was recalled
ALPROSTADIL/LIDOCAINE HCL, 20mcg/5mg/mL, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
- Recalling firm
- Oregon Compounding Centers, Inc. dba Creative Compounds
- Origin
- OR, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0174-2015
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Lidocaine recalls
See all
Class II · Moderate risk Ongoing
Xylocaine
Reason Presence of Particulate Matter: Hair was found in products
Class II · Moderate risk Ongoing
Lidocaine HCl Injection
Reason Presence of Particulate Matter: Hair was found in products
Class III · Low risk Ongoing
Lidolog Kit
Reason Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Class II · Moderate risk Ongoing
Lidocaine HCl Injection USP
Reason Lack of Assurance of Sterility
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