Recalls / Class II
Class IID-1148-2014
Product
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 only, NDC 63323-540-11, 25 vials in tray, each boxed vial individually labeled as: 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 only, NDC 63323-540-11.
- Brand name
- Heparin Sodium
- Generic name
- Heparin Sodium
- Active ingredient
- Heparin Sodium
- Route
- Intravenous, Subcutaneous
- NDCs
- 63323-047, 63323-542, 63323-276, 63323-915, 63323-543, 63323-459, 63323-540, 63323-262
- FDA application
- NDA017651
- Affected lot / code info
- Lot Number: 6004137, Expiration date: 06/2014
Why it was recalled
Subpotent; 18 month time point
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3159 Staley Rd, Grand Island, New York 14072-2028
Distribution
- Quantity
- 161,650 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-01-22
- FDA classified
- 2014-03-05
- Posted by FDA
- 2014-03-12
- Terminated
- 2016-05-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1148-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.