Status
Terminated
Drug Enforcement D-602-2013
Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.
Classification
Class III
Report Date
June 26, 2013
Termination Date
March 18, 2014
Product Information
- Product description
- Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE
- Product quantity
- 8,437 bottles
- Reason for recall
- Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Mission Pharmacal Co
- Address
-
38505 Interstate 10 W
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-602-2013
- Event ID
- 64149
- Recall initiation date
- January 23, 2013
- Center classification date
- June 14, 2013
- Code info
- Lot# E112, Exp 05/14 Lot# J062, Exp 09/14
- More code info
- —