FDA recall D-602-2013

Mission Pharmacal Co · Class III · drug

Product

Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE

Reason for recall

Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2013-01-23
Report date
2013-06-26
Termination date
2014-03-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Boerne, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-602-2013