Drug product
Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE
D-602-2013
Product summary
- Event
- Event 64149
- Status
- Terminated
- Classification
- Class III
- Quantity
- 8,437 bottles
- Official record key
drug-enforcement:D-602-2013
Official wording
Reason: Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.
Code information: Lot# E112, Exp 05/14 Lot# J062, Exp 09/14
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Superpotent