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FDA MedWatch - Specialty Medicine Compounding Pharmacy Certain Unexpired Compounded Sterile Products: Recall - Particulate Matter Found in Vials

While the information contained in this news article was current and accurate when we posted it, it may not necessarily represent current WVOEMS policy or procedure. If you have any questions, please contact our office at 304-558-3956.

Posted: Friday, October 25, 2013 9:18 AM

FDAHeader

Medical Device Safety and Recalls: H and H Medical Corporation (formerly H and H Associates) Emergency Cricothyrotomy Kit Cuff Balloon May Not Function as Intended 10/21/2013

Medical Device Safety and Recalls: CareFusion 211, Inc., AVEA Ventilators, All Models  10/21/2013

FDA MedWatch - Specialty Medicine Compounding Pharmacy Certain Unexpired Compounded Sterile Products: Recall - Particulate Matter Found in Vials  10/21/2013

AUDIENCE: Pharmacy, Patient, Health Professional

ISSUE: Specialty Medicine Compounding Pharmacy is voluntarily recalling all lots of certain unexpired human and veterinary sterile products to the consumer level due to particulate matter found in vials of a compounded dextrose injection product dispensed to a local hospital. Further testing and analysis of the medication is being conducted. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.

BACKGROUND: The recalled products were distributed to hospitals and consumers located only within Michigan from July 1, 2013, through October 19, 2013.  No products were distributed out of state.  Refer to the Firm Press Release for a detailed list of affected products.

RECOMMENDATION: Customers that have product which is being recalled should stop using it and contact the pharmacy to arrange for return of unused product. Customers with questions regarding this recall may contact the pharmacy at 248-446-2643, Monday through Friday, between 8:00 a.m. and 5:00 p.m. EDT. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using these products.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Firm Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm371563.htm

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