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U.S. Department of Health and Human Services

Safety

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Injectable Products made by Central Admixture Pharmacy Service (CAPS) of Lanham, Maryland

Audience: Hospital Risk Managers, Pharmacists and Nursing Supervisory Staff

FDA is notifying healthcare professionals and hospitals about a product recall involving all injectable products manufactured by Central Admixture Pharmacy Services, Inc. of Lanham, Maryland (CAPS) 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 September 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 % and 0.5%, Pain Bags (Bupivicaine 0.25 %)
  • 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 health care workers are urged to examine their supplies for any CAPS of Lanham, MD injectable products and immediately discontinue their use and quarantine the products.

[September 17, 2005 - Recall Notice - CAPS of Lanham, MD]