HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545

FDA device recall Z-1825-2012 · posted 2012-06-19 · Terminated

Recall details

Recalling firm

App Pharmaceuticals Llc

Reason for recall

CGMP Deviations: Incomplete documentation associated with test results.

Action taken

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.

Root cause

Release of Material/Component prior to receiving test results

Status

Terminated

Product code

NZW

Quantity affected

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

Distribution

Nationwide Distribution and Puerto Rico

Date initiated

2010-05-20

Date posted

2012-06-19

Date terminated

2012-06-20

Location

Schaumburg, IL