Drug product
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)
D-604-2013
Product summary
- Event
- Event 65349
- Status
- Terminated
- Classification
- Class III
- Quantity
- 105,744 tubes
- Official record key
drug-enforcement:D-604-2013
Official wording
Reason: Failed Stability Specifications: Unable to meet shelf life expiry.
Code information: Lot # 10301, Exp 05/14 Lot # 10302, Exp 05/14
Distribution pattern: PA, GA, WA, CA
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications