Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Dr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Stability Specifications: Unable to meet shelf life expiry.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
Dr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units, Neomycin Sulfate 3.5mg, Polymyxin-B Sulfate 5,000 units, First Aid Antibiotic Ointment, Net Wt. 0.33oz (9g)
Drug: Neomycin
- Recalling firm
- Faria Limited LLC dba Sheffield Pharmaceuticals
- Origin
- CT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-604-2013 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Neomycin recalls
See all
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Rapidol
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Lil Drug Store
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Circle K
CGMP Deviations; deficiencies observed during FDA inspection
Other recalls by Faria Limited LLC dba Sheffield Pharmaceuticals
All 2013 recalls
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
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 II · Moderate risk
Dr. Sheffield Triple Antibiotic Ointment
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
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