Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, 45 g tubes, Rx Only, Manufactured by Per...
FDA Recall #D-0434-2017 — Class II — December 28, 2016
Product Description
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
Reason for Recall
Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap
Recalling Firm
L. Perrigo Company — Allegan, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
162,534 tubes
Distribution
Nationwide
Code Information
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)
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated