Drug product
Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL bag, Rx only. Hospira Inc, Lake Forest, IL, 60045. NDC: 0409-4196-05
D-1035-2014
Product summary
- Firm
- Hospira Inc.
- Event
- Event 67317
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15258 bags
- Official record key
drug-enforcement:D-1035-2014
Official wording
Reason: Lack of Assurance of Sterility; potential leakage from administrative port.
Code information: Lot #: 26-123-JT, Exp: 8/14
Distribution pattern: Nationwide including Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility