Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel 1.2% and 2.5%…

Date

Dec. 4, 2013

Risk class

Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)

Status

Terminated

Filed by

Valeant Pharmaceuticals North Am

Product

Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel 1.2% and 2.5%, Net Wt. 3.5 g, Rx Only, Sample - not for sale, CORIA Laboratories, a division of Valeant Pharmaceuticals LLC, Bridgewater, NJ 08807 --- NDC 13548-132-03

Reason

Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an incorrect expiration date assigned to a lot of physicians samples.

Distribution pattern

United States

Quantity

45,000 tubes

Codes and lots

Lot AC27198F6

Recall started

Sept. 20, 2013

Recall number

D-020-2014

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-020-2014. The agency record governs; check it and the company before acting.