Recall Z-1825-2012 ยท NZW Heparin, Vascular Access Flush
App Pharmaceuticals Llc
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 int
| Date | Jun 19, 2012 (initiated May 20, 2010) |
| Status | Terminated |
| Reason | CGMP Deviations: Incomplete documentation associated with test results. |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | APP sent an URGENT DRUG RECALL LETTER and Response Form dated May 20, 2010, to all affected consignees. The consignees contacted were at the retail/ medical facilities/hospital IeveIs, including intermediate wholesale IeveIs. Direct distributor consignees were instructed to notify their customers immediately of this recall action, and direct them to discontinue distributing or dispensing the affected lots, plus return the affected products and lots to APP Pharmaceuticals, LLC in Bensenville, IL. Direct consignees with affected lots on hand were instructed to immediately discontinue distribu |
| Quantity | Product Code 504501 (1 mL): 454,275 vials; Product Code 504505 (5 mL): 119,325 vials |
| Distribution | Nationwide Distribution and Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.