Home / Recalls / App Pharmaceuticals Llc / Z-1824-2012

Z-1824-2012 Class II Terminated

Recalled by App Pharmaceuticals Llc — Schaumburg, IL

Recall Details

Product Type
Devices
Report Date
June 27, 2012
Initiation Date
May 20, 2010
Termination Date
June 20, 2012
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
133,150 vials

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.

Distribution Pattern

Nationwide Distribution and Puerto Rico

Code Information

Lot 406952 (Expiration Date 02/11)

Other recalls by App Pharmaceuticals Llc

  • Z-1825-2012 Class II — HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, pl (May 20, 2010)