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Class II: temporary or reversible health riskTerminated

Faria Limited LLC dba Sheffield Pharmaceuticals Dollar General Triple Antibiotic Ointment Recall

Dollar General Triple Antibiotic Ointment

Faria Limited LLC dba Sheffield Pharmaceuticals · New London, CT

Risk level
Class II
Reported by FDA
Feb 12, 2014
Recall ID
D-1078-2014
Check your lot numberHow we source this data

Summary

Faria Limited LLC dba Sheffield Pharmaceuticals recalled Dollar General Triple Antibiotic Ointment starting Nov 22, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1078-2014 on Feb 12, 2014. Reason: Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing. Status: Terminated.

Why it was recalled

Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing

Product description

Dollar General Triple Antibiotic Ointment; NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY DOLGENCORP LLC, GOODLETTSVILLE, TN 37072

Lot numbers, UPCs & expiration codes

20221 EXP. 04/14

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1078-2014
Classification
Class II
Status
Terminated
Recall initiated
Nov 22, 2013
FDA report date
Feb 12, 2014
Quantity
26424
Recall type
Voluntary: Firm initiated
Recalling firm
Faria Limited LLC dba Sheffield Pharmaceuticals

Original FDA data

Every field from FDA enforcement report D-1078-2014, exactly as published.

Show all FDA fields
City
New London
State
CT
Status
Terminated
Country
United States
Event ID
66962
Address
170 Broad St
Code information
20221 EXP. 04/14
Postal code
06320-5313
Report date
Feb 12, 2014
Product type
Drugs
Recall number
D-1078-2014
Classification
Class II
Recalling firm
Faria Limited LLC dba Sheffield Pharmaceuticals
Product quantity
26424
Termination date
Jun 9, 2014
Reason for recall
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Voluntary / mandated
Voluntary: Firm initiated
Product description
Dollar General Triple Antibiotic Ointment; NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY DOLGENCORP LLC, GOODLETTSVILLE, TN 37072
Distribution pattern
Nationwide
Recall initiation date
Nov 22, 2013
Initial firm notification
Letter
Center classification date
Feb 5, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1078-2014, published Feb 12, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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