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Class III: unlikely to cause harmTerminated

Acella Pharmaceuticals Sodium Sulfacetamide 10% Sulfur 4% Cleansing Recall

Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads

Acella Pharmaceuticals, LLC · Alpharetta, GA

Risk level
Class III
Reported by FDA
Dec 7, 2022
Recall ID
D-0074-2023
Check your lot numberHow we source this data

Summary

Acella Pharmaceuticals recalled Sodium Sulfacetamide 10% Sulfur 4% Cleansing starting Nov 14, 2022. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0074-2023 on Dec 7, 2022. Reason: Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period. Status: Terminated.

Why it was recalled

Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.

Product description

Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 300025, NDC 42192-113-60

Lot numbers, UPCs & expiration codes

Lot#: 21084, 21085, Exp 06/30/2023

Where it was sold

USA Nationwide

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-0074-2023
Classification
Class III
Status
Terminated
Recall initiated
Nov 14, 2022
FDA report date
Dec 7, 2022
Quantity
528 cartons
Recall type
Voluntary: Firm initiated
Recalling firm
Acella Pharmaceuticals, LLC

Original FDA data

Every field from FDA enforcement report D-0074-2023, exactly as published.

Show all FDA fields
City
Alpharetta
State
GA
Status
Terminated
Country
United States
Event ID
91150
Address
1880 Mcfarland Pkwy Ste 110
Code information
Lot#: 21084, 21085, Exp 06/30/2023
Postal code
30005-1795
Report date
Dec 7, 2022
Product type
Drugs
Recall number
D-0074-2023
Classification
Class III
Recalling firm
Acella Pharmaceuticals, LLC
Product quantity
528 cartons
Termination date
Aug 1, 2024
Reason for recall
Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 300025, NDC 42192-113-60
Distribution pattern
USA Nationwide
Recall initiation date
Nov 14, 2022
Initial firm notification
Letter
Center classification date
Dec 1, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0074-2023, published Dec 7, 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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