Class II · Moderate risk Ongoing
Xylocaine
Reason Presence of Particulate Matter: Hair was found in products
LTP (Lidocaine 10%, Tetracaine 2%, Phenylephrine 0.5%), Rx only…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: There are also CGMP Deviations.
What was recalled
LTP (Lidocaine 10%, Tetracaine 2%, Phenylephrine 0.5%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
- Recalling firm
- Synergy Rx
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0565-2017
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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