CLASS II Drug recall · Reported 27 Apr 2016 · FDA Enforcement Report
Aminosyn-PF (amino acids) 7%, Sulfite-Free recalled by Hospira
Hospira is recalling Aminosyn-PF (amino acids) 7%, Sulfite-Free, distributed nationwide in the US. The recall was initiated on 8 Mar 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0830-2016
- FDA event ID
- 73472
- Recalling firm
- Hospira, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Mar 2016
- FDA classified
- 21 Apr 2016
- Reported
- 27 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Undeclared Sulfites
Timeline
| 8 Mar 2016 | Recall initiated by company | |
| 21 Apr 2016 | Classified by FDA | +44 days |
| 27 Apr 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Product as listed by the FDA
Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-4178-03 Barcode (01) 0 030409 417803 5
Where it was distributed
US: Nationwide and Singapore
Questions about this recall
Why was it recalled?
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Which lots are affected?
Lot# 49-047-JT, Exp: 07/16
Where was it sold?
US: Nationwide and Singapore
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 73472This product is part of a recall event; the main page for the event is Dextrose Injection, USP, 20%, Packaged as recalled by Hospira.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Dextrose Injection, USP, 20%, Packaged as recalled by Hospira | Hospira | Packaging Defects | Nationwide | |
| CLASS II | Mannitol I.V. recalled by Hospira | Hospira | Packaging Defects | Nationwide | |
| CLASS II | Dextrose Injection, USP, 50%, Packaged as recalled by Hospira | Hospira | Packaging Defects | Nationwide | |
| CLASS II | Dextrose Injection, USP, 70%, Packaged as recalled by Hospira | Hospira | Packaging Defects | Nationwide | |
| CLASS II | Potassium Chloride Injection 20 mEq, 400 mEq/L recalled by Hospira | Hospira | Packaging Defects | Nationwide |
More recalls from Hospira
All 225| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Infant 25% Dextrose Injection recalled by HospiraDextrose | Hospira | Particulate Matter | Nationwide |
| Device | CLASS II | Minibore Extension Set with Spin Lock Collar, Non-DEHP, Latex-Free recalled | Hospira | Other | Nationwide |
| Drug | CLASS III | 5% Lidocaine HCL and 7.5% Dextrose Injection, USP Single-dose ampule recalled | Hospira | Potency & Assay | PR |
| Drug | CLASS II | Fentanyl Citrate Injection, USP, 100 mcg Fentanyl recalled by Hospira | Hospira | Sterility | Nationwide |
| Device | CLASS II | LifeCare PCA 3, PCA recalled by Hospira | Hospira | Device Malfunction | Nationwide |