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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 57878

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 20, 2010
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
App Pharmaceuticals Llc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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.

Z-1824-2012
Recall number
Z-1824-2012
Initiated
May 20, 2010
Classification
Class II
Status
Terminated
Recalling firm
App Pharmaceuticals Llc
Quantity
133,150 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Release of Material/Component prior to receiving test results

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Incomplete documentation associated with test results.

Code information

Lot 406952 (Expiration Date 02/11)

Distribution pattern

Nationwide Distribution and Puerto Rico

device · product 2 of 2

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.

Z-1825-2012
Recall number
Z-1825-2012
Initiated
May 20, 2010
Classification
Class II
Status
Terminated
Recalling firm
App Pharmaceuticals Llc
Quantity
Product Code 504501 (1 mL): 454,275 vials; Product Code 504505 (5 mL): 119,325 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Release of Material/Component prior to receiving test results

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Incomplete documentation associated with test results.

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

Field note

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