Sheffield Triple Antibiotic Ointment
FDA Recall NDC 11527-162
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 Sheffield Triple Antibiotic (NDC 11527-162). A significant event, classified as Class II, was initiated on Nov 22, 2013 by Sheffield Pharmaceuticals Llc. The reported reason for this action was: "Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing"
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
November 2013 Class II Recall: Microbial Contamination of Non-Sterile Products
Recall Number
Class II Terminated
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Nov 22, 2013
Feb 12, 2014
332508
Recall Profile & Regulatory Data
Event ID
66962
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Faria Limited LLC dba Sheffield Pharmaceuticals
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jun 09, 2014
Product Description
Dr. Sheffield Triple Antibiotic Ointment, OTC a) 0.33 oz (9g) (NDC 11527-162-47); b) 1 oz (22g) (NDC 11527-163-55) SHEFFIELD PHARMACEUTICALS, New London, CT 06320
Batch or Lot Expiration Information
Lot# 20154 EXP.12/13, 20153 EXP.12/13, 20152 EXP.12/12, 20151 EXP.12/11, 20093 EXP.12/13, 20092 EXP.12/13, 20091 EXP.12/13, 20085 EXP.12/13, 20084 EXP.12/13, 20083 EXP. 2/13, 20082 EXP.12/13, 20073 EXP. 12/13, 20074 EXP. 12/13, 20075 EXP. 12/13, 20081 EXP.12/13, 20021 EXP. 12/13
Affected Packages Involved in this Recall
11527-162-51Product
11527-162-30Product
11527-162-55Product
11527-162-47Product
11527-162-27Product
11527-163-55Product
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.
