Home

  • Home
    • » e-Newsletters

FDA recalls injectable products from MD pharmacy

Pharmacy Regulation Resource, September 21, 2005

Concerned about sterility, the FDA on September 16 notified hospitals and healthcare professionals about a recall of all injectable products from a Maryland compounding pharmacy.

Tests identified gram negative rod bacteria in two lots of cardioplegia solution manufactured by Central Admixture Pharmacy Services Inc. of Lanham, MD, according to a product safety alert from the FDA. The FDA identified the following products distributed up to September 16 in the recall:

  • 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, oytocin 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

The FDA urged hospitals and healthcare providers to identify in their stock any of those products from Central Admixture Pharmacy Services and discontinue their use.

For more on the recall, visit www.fda.gov/medwatch/safety/2005/safety05.htm#CAPS.

Most Popular