INTEROFFICE MEMORANDUM To: Subject: MAPMG Providers, Nurse Practitioners, Physician Assistants, Pharmacy Staff CLASS I DRUG RECALL: Date: October 17, 2014 From: Sheireen Huang, Pharm.D. Manager, Clinical Pharmacy Services and Carol Forster, MD Physician Director, Pharmacy and Therapeutics/Medication Safety Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu Flex II Container Manufactured by Baxter Healthcare Corp. Situation: A Class I Recall has been issued for two lots of Dianeal Low Calcium (2.5 mEq/L) peritoneal dialysis solution with 2.5% dextrose manufactured by Baxter Healthcare Corp. due to the discovery of oxidized stainless steel, garment fiber, and PVC particulate matter. The Food and Drug Administration reclassified a nationwide voluntary product recall that was previously issued on August 7, 2014. Background: DIANEAL peritoneal dialysis solution is a hypertonic peritoneal dialysis solution containing dextrose, a monosaccharide, as the primary osmotic agent used in the management of acute or chronic renal failure when nondialytic medical therapy is judged to be inadequate. Risk factors associated include the potential for particulate to be injected and/or a delay in therapy. Free-floating particulates may pass through the catheter and result in local inflammation, and/or mechanical disruption of tissue or immune response to the particulate. Chronically, following sequestration, local granuloma formulation may occur. To date there have been no complaints or adverse events reported to Baxter Healthcare Corp. The lots listed in the table below are recalled: Product Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, in 5,000 mL Ambu-Flex II Container NDC: 00941-0457-05 LOT / EXP: C940700 – 05/31/2016 C940841 – 05/31/2016 A Class I recall is a situation in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. Assessment A Class I Recall has been issued for two lots of Dianeal Low Calcium (2.5 mEq/L) peritoneal dialysis solution with 2.5% dextrose manufactured by Baxter Healthcare Corp. due to the discovery of oxidized stainless steel, garment fiber, and PVC particulate matter. The KPMAS region had no pharmacy purchases of the recalled medication. KPMAS pharmacies were notified of this Class I recall on Tuesday, October 14, 2014 and a quantity-on-hand count confirmed no product on-hand in pharmacy and clinical areas. Materials Management was notified of this Class I recall. No patients were dispensed this medication within the past 30 days from an internal or network affiliated pharmacy. Recommendations/Action Requested: 1. Prescribing providers and pharmacy staff should be aware of this Class I recall, as there are potential patient safety implications. 2. Pharmacies and Materials Management were informed of the Class I recall. Inventory was checked in the pharmacy and clinic areas to ensure that any recalled product was removed. 3. Communication will be sent to KPMAS providers and will be posted on the internal KPMAS Pharmacy PITHELP web site and the external Community Provider Portal. Thank you for your attention to this recall notice. References: 1. FDA Enforcement Reports dated Week of October 7, 2014 (Dianeal Low Calcium (2.5 mEq/L) peritoneal dialysis solution with 2.5% dextrose), accessed 10/15/14. 2. Dianeal Low Calcium (2.5 mEq/L) peritoneal dialysis solution with 2.5% dextrose, Daily Med, accessed 10/15/14. 3. KPMAS Pharmacy Distribution Center Class I Recall Notifications (sent 10/14/14) 1