December 2016 FDA Recall Clindamycin Phosphate And Benzoyl Peroxide by L. Perrigo Company
D-0434-2017 - Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap

This Class II drug recall was voluntarily initiated by L. Perrigo Company on December 28, 2016 for the product Clindamycin Phosphate And Benzoyl Peroxide. The FDA reported the reason for recall as microbial contamination of non-sterile product; small number of tubes may include the presence of mold on the cap. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0434-2017

Reason for Recall
Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap
Initiated
12-28-2016
Reported
01-25-2017
Quantity
162,534 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76061
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
L. Perrigo Company
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-22-2017
Product Description About Product Description
Full technical description of the product.
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, 45 g tubes, Rx Only, Manufactured by Perrigo, Yeruham, Israel, Distributed by Perrigo, Allegan, MI --- NDC 45802-736-84, UPC 345802736840

Batch or Lot Expiration Information

Lot# 080806 (exp 12/16) 080844 ( exp 12/16) 080963 (exp 12/16) 080999 ( exp 12/16) 0841 09 ( exp 03/17 084197 ( exp 03/17) 091 090 ( exp 1 0/17) 092319 (exp 11/17) 092399 ( exp 12/17) 092440 ( exp 12/17)

Affected Packages Involved in this Recall

45802-736-84 Clindamycin Phosphate And Benzoyl Peroxide