Recalls / Class II
Class IID-1035-2014
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
- Affected lot / code info
- Lot #: 26-123-JT, Exp: 8/14
Why it was recalled
Lack of Assurance of Sterility; potential leakage from administrative port.
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 15258 bags
- Distribution pattern
- Nationwide including Puerto Rico
Timeline
- Recall initiated
- 2014-01-09
- FDA classified
- 2014-01-24
- Posted by FDA
- 2014-02-05
- Terminated
- 2015-05-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1035-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.