Skip to content
Recall Observatory FDA recall evidence

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

January 23, 2013

Class III

Product summary

Firm
Mission Pharmacal Co
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

    reason.potency_specification_failure · v1.0.0

    Superpotent