D-602-2013 Class III Terminated
FDA drug recall D-602-2013 was initiated by Mission Pharmacal Co on January 23, 2013 and is designated Class III. Reason for recall: Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength. The recall status is terminated (terminated March 18, 2014). Affected quantity: 8,437 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 26, 2013
- Initiation Date
- January 23, 2013
- Termination Date
- March 18, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,437 bottles
Product Description
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 Pattern
Nationwide
Code Information
Lot# E112, Exp 05/14 Lot# J062, Exp 09/14