Reported Jun 27, 2012 · Terminated
HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC…
App Pharmaceuticals LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: App Pharmaceuticals Llc · 1501 E Woodfield Rd · Schaumburg, IL · 60173-6052
Is this the product you have?
3 of 3 products
| Model / number | Product as published |
|---|---|
504501 | HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01 |
504505 | 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 |
| — | Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling. |
- Lot codes and dates
- 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)
- Amount recalled
- Product Code 504501 (1 mL): 454,275 vials; Product Code 504505 (5 mL): 119,325 vials
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
CGMP Deviations: Incomplete documentation associated with test results.
This product could cause temporary or reversible health problems — stop using it.
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