Recalls / Class III
Class IIID-0074-2023
Product
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
- Affected lot / code info
- Lot#: 21084, 21085, Exp 06/30/2023
Why it was recalled
Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Recalling firm
- Firm
- Acella Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1880 Mcfarland Pkwy Ste 110, Alpharetta, Georgia 30005-1795
Distribution
- Quantity
- 528 cartons
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2022-11-14
- FDA classified
- 2022-12-01
- Posted by FDA
- 2022-12-07
- Terminated
- 2024-08-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0074-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.