Reported Aug 15, 2018 · Terminated

Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville,…

Akorn, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Akorn, Inc. · 1925 W Field Ct Ste 300 · Lake Forest, IL · 60045-4862

Is this the product you have?

    • Lidocaine 2.5% and Prilocaine Cream
    • 2.5%. 30g tube
    • Rx only
  • Manufactured byHi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-667-30
Lot codes and dates
    • Lot #: 356309
    • Exp. 3/2019
Amount recalled
22,605 tubes

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Nov 6, 2020 · Data as of Sep 19, 6:33 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.