D-1035-2014 Class II Terminated
FDA drug recall D-1035-2014 was initiated by Hospira Inc. on Jan 9, 2014 and is designated Class II. Reason for recall: Lack of Assurance of Sterility; potential leakage from administrative port. The recall status is terminated (terminated May 19, 2015). Affected quantity: 15258 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 5, 2014
- Initiation Date
- Jan 9, 2014
- Termination Date
- May 19, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15258 bags
Product Description
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
Reason for Recall
Lack of Assurance of Sterility; potential leakage from administrative port.
Distribution Pattern
Nationwide including Puerto Rico
Code Information
Lot #: 26-123-JT, Exp: 8/14
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1035-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026