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U.S. Department of Health and Human Services

Enforcement Report - Week of June 27, 2012

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 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) Class II CGMP Deviations: Incomplete documentation associated with test results. Product Code 504501 (1 mL): 454,275 vials; Product Code 504505 (5 mL): 119,325 vials Z-1825-2012
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. Lot 406952 (Expiration Date 02/11) Class II CGMP Deviations: Incomplete documentation associated with test results. 133,150 vials Z-1824-2012
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