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Class II: temporary or reversible health riskTerminated

Direct Rx Diclofenac Sodium Topical Solution 1 Recall

Diclofenac Sodium Topical Solution 1

Direct Rx · Dawsonville, GA

Risk level
Class II
Reported by FDA
Mar 30, 2022
Recall ID
D-0714-2022
Check your lot numberHow we source this data

Summary

Direct Rx recalled Diclofenac Sodium Topical Solution 1 starting Dec 7, 2021. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0714-2022 on Mar 30, 2022. Reason: Defective Container: Leaking containers. Status: Terminated.

Why it was recalled

Defective Container: Leaking containers.

Product description

Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534 Mfg. For SOLA Pharmaceuticals Baton Rouge, LA, NDC 61919-675-05

Lot numbers, UPCs & expiration codes

Lot #: 24MA2010 Exp. 1/31/2023

Where it was sold

Nationwide within the United States

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0714-2022
Classification
Class II
Status
Terminated
Recall initiated
Dec 7, 2021
FDA report date
Mar 30, 2022
Quantity
312 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Direct Rx

Original FDA data

Every field from FDA enforcement report D-0714-2022, exactly as published.

Show all FDA fields
City
Dawsonville
State
GA
Status
Terminated
Country
United States
Event ID
89807
Address
94 Worldwide Dr
Code information
Lot #: 24MA2010 Exp. 1/31/2023
Postal code
30534-6828
Report date
Mar 30, 2022
Product type
Drugs
Recall number
D-0714-2022
Classification
Class II
Recalling firm
Direct Rx
Product quantity
312 bottles
Termination date
Oct 5, 2023
Reason for recall
Defective Container: Leaking containers.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534 Mfg. For SOLA Pharmaceuticals Baton Rouge, LA, NDC 61919-675-05
Distribution pattern
Nationwide within the United States
Recall initiation date
Dec 7, 2021
Initial firm notification
Letter
Center classification date
Mar 22, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0714-2022, published Mar 30, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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