HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710
Reported: February 4, 2015 Initiated: December 19, 2014 #Z-1032-2015
Product Description
HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710
Reason for Recall
The lot failed pH specification.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- Domestic: 69,725
- Distribution
- Nationwide Distribution
- Location
- Lake Zurich, IL
Frequently Asked Questions
What product was recalled? ▼
HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710. Recalled by Fresenius Kabi USA, LLC. Units affected: Domestic: 69,725.
Why was this product recalled? ▼
The lot failed pH specification.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 4, 2015. Severity: Moderate. Recall number: Z-1032-2015.
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