Status
Terminated
Drug Enforcement D-0074-2023
Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Classification
Class III
Report Date
December 7, 2022
Termination Date
August 1, 2024
Product Information
- 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
- Product quantity
- 528 cartons
- Reason for recall
- Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- USA Nationwide
Location & Firm
- Recalling firm
- Acella Pharmaceuticals, LLC
- Address
-
1880 Mcfarland Pkwy Ste 110
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0074-2023
- Event ID
- 91150
- Recall initiation date
- November 14, 2022
- Center classification date
- December 1, 2022
- Code info
- Lot#: 21084, 21085, Exp 06/30/2023
- More code info
- —