Drug Enforcement D-046-2013

Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient.

Status

Terminated

Classification

Class III

Report Date

November 14, 2012

Termination Date

March 25, 2013

Product Information

Product description
AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v); 60-count pads per jar, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13551 6.
Product quantity
71,369 jars
Reason for recall
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient.
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Valeant Pharmaceuticals
Address
700 Rte 206 North, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-046-2013
Event ID
63488
Recall initiation date
October 15, 2012
Center classification date
November 6, 2012
Code info
All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13551 6
More code info