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.
Reported: March 12, 2014 Initiated: January 22, 2014 #D-1148-2014
Product Description
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.
Reason for Recall
Subpotent; 18 month time point
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 161,650 vials
- Distribution
- Nationwide
- Location
- Grand Island, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Fresenius Kabi USA, LLC. Units affected: 161,650 vials.
Why was this product recalled? ▼
Subpotent; 18 month time point
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 12, 2014. Severity: Moderate. Recall number: D-1148-2014.
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