App Pharmaceuticals Llc: Medical Device Recall in 2012 - (Recall #: Z-1825-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: May 20, 2010

Date Posted: June 27, 2012

Recall Number: Z-1825-2012

Event ID: 57878

Reason for Recall:

CGMP Deviations: Incomplete documentation associated with test results.

Status: Terminated

Product Quantity: Product Code 504501 (1 mL): 454,275 vials; Product Code 504505 (5 mL): 119,325 vials

Code Information:

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)

Distribution Pattern:

Nationwide Distribution and Puerto Rico

Voluntary or Mandated:

Voluntary: Firm initiated