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 |
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