Class II · Moderate risk Ongoing
Xylocaine
Reason Presence of Particulate Matter: Hair was found in products
Benzocaine 20%
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
What was recalled
Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
- Recalling firm
- KRS Global Biotechnology, Inc
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0166-2018
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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