Z-1825-2012Class II

HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL...

Name: Z-1825-2012 HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL...
Creator: App Pharmaceuticals Llc
Published: 2010-05-20
License: https://open.fda.gov/license/

Fresenius Kabi USA, LLC / initiated 2010-05-20 / Terminated

FDA source

App Pharmaceuticals Llc began a recall of 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... on 2010-05-20. FDA classified it as Class II and gives the reason as "CGMP Deviations: Incomplete documentation associated with test results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1825-2012
Classification: Class II
Status: Terminated
Initiated: 2010-05-20
Posted: 2012-06-19
Terminated: 2012-06-20
Recalling firm: Fresenius Kabi USA, LLC
Product: 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.
Product code: NZW Heparin, Vascular Access Flush
Reason for recall: CGMP Deviations: Incomplete documentation associated with test results.
FDA 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 distributing or dispensing the affected products and return them to APP Pharmaceuticals, LLC in Bensenville, IL 60106. Questions regarding the information on how to return product can be made to the firm's Quality Assurance Department at 1-866-716-2459. For questions regarding this recall call 847-969-2700.
Quantity in commerce: Product Code 504501 (1 mL): 454,275 vials; Product Code 504505 (5 mL): 119,325 vials
Distribution: Nationwide Distribution and Puerto Rico
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1825-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1824-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-19
Z-1825-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-19

Product code NZW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)