D-604-2013 Class III Terminated
FDA drug recall D-604-2013 was initiated by Faria Limited LLC dba Sheffield Pharmaceuticals on May 28, 2013 and is designated Class III. Reason for recall: Failed Stability Specifications: Unable to meet shelf life expiry. The recall status is terminated (terminated March 28, 2014). Affected quantity: 105,744 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- June 26, 2013
- Initiation Date
- May 28, 2013
- Termination Date
- March 28, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 105,744 tubes
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)
Reason for Recall
Failed Stability Specifications: Unable to meet shelf life expiry.
Distribution Pattern
PA, GA, WA, CA
Code Information
Lot # 10301, Exp 05/14 Lot # 10302, Exp 05/14