Why it was recalled
Lack of Assurance of Sterility; potential leakage from administrative port.
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
Lot numbers, UPCs & expiration codes
Lot #: 26-123-JT, Exp: 8/14
Where it was sold
Nationwide including Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1035-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 9, 2014
- FDA report date
- Feb 5, 2014
- Quantity
- 15258 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-1035-2014, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 67317
- Address
- 275 N Field Dr
- Code information
- Lot #: 26-123-JT, Exp: 8/14
- Postal code
- 60045-2579
- Report date
- Feb 5, 2014
- Product type
- Drugs
- Recall number
- D-1035-2014
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 15258 bags
- Termination date
- May 19, 2015
- Reason for recall
- Lack of Assurance of Sterility; potential leakage from administrative port.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide including Puerto Rico
- Recall initiation date
- Jan 9, 2014
- Initial firm notification
- Letter
- Center classification date
- Jan 24, 2014