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U.S. Department of Health and Human Services

Enforcement Report - Week of June 27, 2012

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Product Detail

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.
Recall Number Z-1825-2012
Classification Class II
Code Info 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)
Product Distributed Qty Product Code 504501 (1 mL): 454,275 vials; Product Code 504505 (5 mL): 119,325 vials
Reason For Recall CGMP Deviations: Incomplete documentation associated with test results.

Event Detail

Event Id 57878
Product Type Devices
Status Terminated
Recalling Firm App Pharmaceuticals Llc
City Schaumburg
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-05-20
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution and Puerto Rico