Medefil Heparin I.V. Flush Syringe 100 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 100 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# 64253-333-33, catalog # MIH-3333: 3 mL fill in 12 mL syringe; b) NDC# 64253-333-35, catalog # MIH-3335: 5 mL fill in 12 mL syringe
This recall has been terminated (originally issued December 10, 2010).
- Company
- Medefil Incorporated
- Recall Initiated
- November 1, 2010
- Posted
- December 10, 2010
- Terminated
- February 13, 2012
- Recall Number
- Z-0599-2011
- Quantity
- 1,996,500 syringes
- Firm Location
- Glendale Heights, IL
- Official Source
- View on FDA website ↗
Reason for Recall
The heparin lock flush solution was manufactured with contaminated Heparin Sodium USP Active Pharmaceutical Ingredient (API).
Distribution
Nationwide Distribution --- including states of Arizona, California, Florida, Illinois, Ohio, Louisiana, Massachusetts, Michigan, Minnesota, New York, Texas, and Virginia.
Lot / Code Info
a) catalog # MIH-3333: Lot H109298, exp. date 08/11; Lot H110152, exp. date 01/12; b) catalog # MIH-3335: Lot H109291, exp. date 08/11; Lot H109293, exp. date 08/11; Lot H109295, exp. date 08/11; Lot H109297, exp. date 08/11; H109299, exp. date 08/11; Lot H109300, exp. date 08/11.
Root 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.