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Class III: unlikely to cause harmTerminated

Acella Pharmaceuticals Sodium Sulfacetamide 10% Recall

Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170

Acella Pharmaceuticals, LLC · Alpharetta, GA

Risk level
Class III
Reported by FDA
May 15, 2024
Recall ID
D-0490-2024
Check your lot numberHow we source this data

Summary

Acella Pharmaceuticals recalled Sodium Sulfacetamide 10% starting Apr 24, 2024. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0490-2024 on May 15, 2024. Reason: Subpotent drug. Status: Terminated.

Why it was recalled

Subpotent drug

Product description

Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06

Lot numbers, UPCs & expiration codes

Lot # 22085 Exp. date 08/02/2024

Where it was sold

Nationwide in the US and Puerto Rico.

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-0490-2024
Classification
Class III
Status
Terminated
Recall initiated
Apr 24, 2024
FDA report date
May 15, 2024
Quantity
7104 Bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Acella Pharmaceuticals, LLC

Original FDA data

Every field from FDA enforcement report D-0490-2024, exactly as published.

Show all FDA fields
City
Alpharetta
State
GA
Status
Terminated
Country
United States
Event ID
94485
Address
1880 Mcfarland Pkwy Ste 110
Code information
Lot # 22085 Exp. date 08/02/2024
Postal code
30005-1795
Report date
May 15, 2024
Product type
Drugs
Recall number
D-0490-2024
Classification
Class III
Recalling firm
Acella Pharmaceuticals, LLC
Product quantity
7104 Bottles
Termination date
Dec 22, 2025
Reason for recall
Subpotent drug
Voluntary / mandated
Voluntary: Firm initiated
Product description
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06
Distribution pattern
Nationwide in the US and Puerto Rico.
Recall initiation date
Apr 24, 2024
Initial firm notification
Letter
Center classification date
May 8, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0490-2024, published May 15, 2024. 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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