Drug 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
D-0074-2023
Product summary
- Event
- Event 91150
- Status
- Terminated
- Classification
- Class III
- Quantity
- 528 cartons
- Official record key
drug-enforcement:D-0074-2023
Official wording
Reason: Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Code information: Lot#: 21084, 21085, Exp 06/30/2023
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent