Clindamycin Phosphate And Benzoyl Peroxide Gel
FDA Recall NDC 45802-736
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Clindamycin Phosphate And Benzoyl Peroxide (NDC 45802-736). A significant event, classified as Class II, was initiated on Dec 28, 2016 by Padagis Israel Pharmaceuticals Ltd. The reported reason for this action was: "Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
December 2016 Class II Recall: Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap
Recall Number
Class II Terminated
Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap
Dec 28, 2016
Jan 25, 2017
162,534 tubes
Recall Profile & Regulatory Data
Event ID
76061
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
L. Perrigo Company
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Aug 22, 2017
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
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
45802-736-84Product
3458027368Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
