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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
March 3, 1999

PRODUCT
Generic pre-filled syringes aseptically manufactured and
distributed by Medefil:
a) 0.9% Sodium Chloride Injection, USP, Preservative Free
   2ml fill in 3 ml syringe - NDC #64253-777-12;
   5 ml fill in 6 ml syringe - NDC #64253-777-25;
   10 ml fill in 12 ml syringe - NDC #64253-777-30;
   5 ml fill in 12 ml syringe - NDC #64253-777-35;
b) Heparin Sodium 10 units/ml in 0.9% Sodium Chloride Injection,
   USP, 5 ml fill in 12 ml syringe - NDC #64253-666-35;
c) Heparin Sodium 100 units/ml in 0.9% Sodium Chloride Injection
   USP
   3ml fill in 6 ml syringe - NDC #64253-555-23;
   5 ml fill in 6 ml syringe - NDC #64253-555-25;
   10 ml fill in 12 ml syringe - NDC #64253-555-30;
   5 ml fill in 12 ml syringe - NDC #64253-555-35.
Recall #D-126/128-9.

CODE
All lots: S00005, S00006, S00007, S00008, S00009, S00010, S00011, S00012, S00013, S00014, S00015, S00017, S00018, S00019, S00020, S00021, S00022, S00023, S00024, S00025, H00005, H100005, H100006, H100007, H100008, H100009.

MANUFACTURER
Medefil, Inc., Schaumburg, Illinois.

RECALLED BY
Manufacturer, by letter dated February 8, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Ohio.

QUANTITY
a) 1,532 cases; b) 25 cases; c) 262 cases were distributed between 12/18/98 and 1/28/99; firm estimated that 50% of the product remained on the market at time of recall initiation.

REASON
Products were marketed without approved (NDA/ANDA) and numerous deviations from current good manufacturing practices (GCMP's) related to sterile drug production.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.