Status
Terminated
Drug Enforcement D-604-2013
Failed Stability Specifications: Unable to meet shelf life expiry.
Classification
Class III
Report Date
June 26, 2013
Termination Date
March 28, 2014
Product Information
- 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)
- Product quantity
- 105,744 tubes
- Reason for recall
- Failed Stability Specifications: Unable to meet shelf life expiry.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- PA, GA, WA, CA
Location & Firm
- Recalling firm
- Faria Limited LLC dba Sheffield Pharmaceuticals
- Address
-
170 Broad St
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-604-2013
- Event ID
- 65349
- Recall initiation date
- May 28, 2013
- Center classification date
- June 14, 2013
- Code info
- Lot # 10301, Exp 05/14 Lot # 10302, Exp 05/14
- More code info
- —