CAPS Injectable Products Recalled, Gram-Negative Rods Found

The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals and hospitals about a product recall involving all injectable products manufactured by Central Admixture Pharmacy Services, Inc. (CAPS) of Lanham, Md. due to concerns regarding the sterility of these injectable products. CAPS distributed the affected injectable products to hospitals in Maryland, Delaware, Washington, D.C., and Virginia. Gram-negative rods have been identified in two lots of Cardioplegia solution manufactured by CAPS. Non-sterility of injectable products could represent a serious hazard to health that could lead to life-threatening injuries and death.

The following products distributed up to Sept. 16, 2005, are affected by this action:

           Cardioplegia solutions including: Cardioplegia, Cold Cardioplegia, Warm Cardioplegia, Blood Cardioplegia 1, Blood Cardioplegia 2, Cardioplegia Base 1, Cardioplegia Base 2, Cardioplegia Base, Cardioplegia Reperfusion, Cardioplegia High Potassium, Cardioplegia Low Potassium, Cardioplegia #1, Cardioplegia #2 Cardioplegia #3; Maintenance Cardioplegia, Enriched Cardioplegia, Cardioplegia Hot Shot, Cardioplegia Base Enriched

           Oxytocin injectable products including: Oxytocin Infusion, Oxytocin 20 units, Oxytocin 30 units, Oxytocin D5 ½ NS, Oxytocin in Lactated Ringers

           Promethazine

           Magnesium-containing injectable products including: Magnesium 1 GM, Magnesium 2 GM, Magnesium Sulfate 2 GM, Magnesium 4 GM, Hydration-Magnesium in D5W, Magnesium Infusion, Magnesium in Lactated Ringers

           Heparin Replacement

           Antibiotic Irrigation Bag and Bottle

           Bupivicaine 0.25 percent and 0.5 percent, Pain Bags (Bupivicaine 0.25  percent)

           Dialysate solutions including: Citrate Dialysate, Heparin Dialysate, Pediatric Dialysate, Hydration Dialysate #1, Hydration Dialysate #2, CRRT Dialysate, CVVHD (Dialysate) 300, CVVHD (Dialysate) 342, CVVHD Pediatric Formula (Normocarb), CVVHD Formalin #1, CVVHD Formalin #2, CVVHD Formalin #3, CVVHD Non-Standard, CVVHD D5W, CVVHD ½ NS, CVVHD NS

           Total Parenteral Nutrition (TPN) products including: TPN-Day, TPN-Day 1 Neonatal Stock Solution

           Diltiazem (Cardizem)

           Norepinephrine (Levophed)

           Cefazolin

Although CAPS has directly notified known hospital customers of the recall, hospitals, physicians, and healthcare workers are urged to examine their supplies for any CAPS injectable products and immediately discontinue their use and quarantine the products.

Source: U.S. Food and Drug Administration