Class II · Moderate risk
Dollar General Triple Antibiotic Ointment
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Dr. Sheffield Triple Antibiotic Ointment
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
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
Affected NDCs
11527-0162-47
11527-0163-55
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product codes this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Sheffield Triple Antibiotic Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate NDC 11527-0162 |
BACITRACIN ZINC 400 [USP'U]/g; POLYMYXIN B SULFATE 5000 [USP'U]/g; NEOMYCIN SULFATE 3.5 mg/g | Ointment Topical |
Sheffield Pharmaceuticals LLC | OTC |
| Sheffield Bacitracin Zinc Bacitracin Zinc NDC 11527-0163 |
500 [USP'U]/g | Ointment Topical |
Sheffield Pharmaceuticals LLC | OTC |
- Recalling firm
- Faria Limited LLC dba Sheffield Pharmaceuticals
- NDC code
- 11527-162-47
- Origin
- CT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1076-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Faria Limited LLC dba Sheffield Pharmaceuticals
All 2013 recalls
Class II · Moderate risk
FAMILY wellness Triple Antibiotic Ointment. NET WT 1 OZ
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Class III · Low risk
Dr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units
Failed Stability Specifications: Unable to meet shelf life expiry.
Other microbial contamination recalls from 2013
All microbial contamination recalls
Class II · Moderate risk
Mangiacotti - Ginger Lime Hand Sanitizer Spray
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Class II · Moderate risk
Mangiacotti - Pomegranate Hand Sanitizer Spray
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Class II · Moderate risk
Mangiacotti - Clementine Hand Sanitizer Spray
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Class II · Moderate risk
Mangiacotti - Ocean Hand Sanitizer Spray
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
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