Recall Z-1824-2012— App Pharmaceuticals Llc
Class II · Terminated
Class II FDA medical device recall by App Pharmaceuticals Llc, initiated 2010-05-20, terminated 2012-06-20. FDA's recall record names no specific 510(k) clearance for this event. Product: HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.. Reason: CGMP Deviations: Incomplete documentation associated with test results..
- Recalling firm
- App Pharmaceuticals Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2010-05-20
- Terminated
- 2012-06-20
- Firm location
- Schaumburg, IL, United States
Product description
HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
Reason for recall
CGMP Deviations: Incomplete documentation associated with test results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.