FDAFDA · Food and drugs·Recall number Z-1825-2012
HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 5 mL Multiple Dose Vial, 500 USP Units/5 mL, plastic vial, vial size 6 mL, NDC 63323-545-05, Product Code 504505; Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
Published June 27, 2012 · Recall initiated: May 20, 2010
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Incomplete documentation associated with test results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- App Pharmaceuticals Llc
- Distributor
- Nationwide Distribution and Puerto Rico
- Lot
- Product Code 504501 (1 mL): Lot 406912 (Expiration Date 01/11) and Lot 408072 (Expiration Date 09/11); Product Code 504505 (5 mL): Lot 406914 (Expiration Date 01/12)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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