Recall Z-0601-2011
Medefil Incorporated · initiated November 1, 2010
Product
Medefil Heparin I.V. Flush Syringe 1 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 1 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc. Glendale Heights, IL 60139. The pre-filled syringes were packed as 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: a) NDC# 64253-444-22, catalog # MIH-4422: 2 mL fill in 6 mL syringe; b) NDC# 64253-444-25, catalog # MIH-4425: 5 mL fill in 6 mL syringe
Codes / lots: a) catalog # MIH-4422: Lot H210209, exp. date 04/12; Lot H210238, exp. date 05/12; Lot H210265, exp. date 05/12; b) catalog # MIH-4425: Lot H210210, exp. date 04/12; H210241, exp. date 05/12.
Reason for recall
The heparin lock flush solution was manufactured with contaminated Heparin Sodium USP Active Pharmaceutical Ingredient (API).
FDA-determined cause: Material/Component Contamination
Action taken
Medefil faxed/emailed the direct accounts on 11/1/10, and sent the accounts a hard copy of the Urgent Product Recall letter, dated 11/1/2010, on 11/2/10. The accounts were informed of Medefil's recall of 18 lots of Heparin I.V. Flush Syringes produced from the active pharmaceutical ingredient (API) Heparin Sodium, USP, lot 1035-0780, that has been recalled by the manufacturer, Scientific Protein Laboratories, due to the presence of a contaminant, Oversulfated Chondroitin Sulfate. The accounts were instructed to stop use of the 18 lots of Heparin I.V. Flush Syringes immediately, place them under quarantine, and contact Medefil to arrange for the product to be returned. The accounts were requested to complete and return to Medefil the enclosed response form, indicating the quantity on hand of each recalled lot. Any questions were directed to Pradeep Aggarwal, President at 630-682-4600.
Details
- Recall number
- Z-0601-2011
- Initiated
- November 1, 2010
- Posted by FDA
- December 10, 2010
- Terminated
- February 13, 2012
- Product code
- NZW – Heparin, Vascular Access Flush
- Quantity
- 339,180 syringes
- Distribution
- Nationwide Distribution --- including states of Arizona, California, Florida, Illinois, Ohio, Louisiana, Massachusetts, Michigan, Minnesota, New York, Texas, and Virginia.
- Recalling firm
- Medefil Incorporated, Glendale Heights, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0599-2011 | Medefil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe…The heparin lock flush solution was manufactured with contaminated Heparin Sodium USP Active Pharmaceutical… | 11/01/2010Terminated |
| Z-0600-2011 | Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe…The heparin lock flush solution was manufactured with contaminated Heparin Sodium USP Active Pharmaceutical… | 11/01/2010Terminated |