Why it was recalled
Failed Stability Specifications: Unable to meet shelf life expiry.
Product description
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)
Lot numbers, UPCs & expiration codes
Lot # 10301, Exp 05/14 Lot # 10302, Exp 05/14
Where it was sold
PA, GA, WA, CA
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-604-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 28, 2013
- FDA report date
- Jun 26, 2013
- Quantity
- 105,744 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Faria Limited LLC dba Sheffield Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-604-2013, exactly as published.
Show all FDA fields
- City
- New London
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 65349
- Address
- 170 Broad St
- Code information
- Lot # 10301, Exp 05/14 Lot # 10302, Exp 05/14
- Postal code
- 06320-5313
- Report date
- Jun 26, 2013
- Product type
- Drugs
- Recall number
- D-604-2013
- Classification
- Class III
- Recalling firm
- Faria Limited LLC dba Sheffield Pharmaceuticals
- Product quantity
- 105,744 tubes
- Termination date
- Mar 28, 2014
- Reason for recall
- Failed Stability Specifications: Unable to meet shelf life expiry.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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)
- Distribution pattern
- PA, GA, WA, CA
- Recall initiation date
- May 28, 2013
- Initial firm notification
- Letter
- Center classification date
- Jun 14, 2013