Reported Mar 12, 2014 · Terminated
Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx…
Fresenius Kabi USA, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Kabi USA, LLC · 3159 Staley Rd · Grand Island, NY · 14072-2028
Is this the product you have?
Heparin Sodium InjectionUSP 10000 USP units per 10 mL (1000 USP units per mL) For IV or SC useMulti-Dose VialRx onlyNDC 63323-540-1125 vials in tray
- each boxed vial individually labeled asHeparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11
- Lot codes and dates
- Lot Number6004137
- Expiration date06/2014
- Amount recalled
- 161,650 vials
Where it was sold
- Nationwide
Why it was recalled
Subpotent; 18 month time point
This product could cause temporary or reversible health problems — stop using it.
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