Moderate riskFDA DrugClass II

Direct Rx lidocaine ointment recalled for subpotent drug strength

Direct Rx is recalling 493 jars of Lidocaine Ointment USP, 5.0%, 50g, because the product may contain less lidocaine than its label states. The affected lots are 03AP2511, 30AP2518, 18JU2519, and 18JU2520, with an expiration date of 04/30/2027. The product was distributed nationwide, and no injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Check the lot number on the jar against the affected lots listed above.
  2. If your jar matches, ask your pharmacist or doctor about a replacement before you stop using it.
  3. Contact Direct Rx with questions about the recall.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Lidocaine Ointment USP, 5.0 % 50g JAR, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534, NDC 72189-0211-50
Sold in
Nationwide
Made for
Adults (under 0 months)

Details

Units affected
493 jars
Illnesses reported
None reported
Manufactured in
94 Worldwide Dr, Dawsonville, Georgia, United States
Classification
Class II
Recall number
D-0107-2027

In the FDA's words

Description
Lidocaine Ointment USP, 5.0 % 50g JAR, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534, NDC 72189-0211-50 Subpotent Drug LOT#: 03AP2511, 30AP2518, 18JU2519, 18JU2520, Exp. Date 04/30/2027. Distribution: Nationwide within the United States Affected quantity: 493 jars
Hazard
Subpotent Drug

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