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Menactra approved in children age 9 months and older: Meningococcal disease is a life-threatening disease where 10 to 20 percent of those infected die, or suffer certain complications such as brain damage and hearing loss. Neisseria meningitides has been identified as the leading bacteria that infects the bloodstream, lining that surrounds the brain, and spinal cord. For children this disease can be particularly dangerous as it progresses rapidly and has symtoms very similar to the influenza and other common illnesses.

On April 22, 2011, The Food and Drug Administration has approved the use of Menactra in children as young as 9 months old. Menactra has already been approved for patients between the ages of 2 and 55.

(For more information, visit www.fda.gov)

Recalls:

  • Ammonium Molybdate Injection, USP (Molybdenum 250mcg/10mL) 10mL Single Dose Vial
  • Ammonium Molybdate Injection, USP is indicated for use as a supplement to Total Parenteral Nutrition (TPN) solutions.

According to the press release issued by American Regent on April 26, 2011, Hospitals, Infusion Centers, Clinics and other healthcare facilities should not use American Regent Inc., Ammonium Molybdate Injection, USP, Lot # 9409, for patient care and should immediately quarantine any product for return. While American Regent continues to investigate this issue, the company is taking precautionary action and initiated this voluntary recall.  American Regent has informed the FDA of its actions and is maintaining ongoing discussions with the Agency.

As is standard practice, and as stated in the Ammonium Molybdate Injection, USP, Product Package Insert, "Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit."

February News from the FDA

February 2011

FDA reminds health care professionals about safe use of non-sterile alcohol prep pads:

After The Triad Group of Harland, Wis., recalled all lots of its alcohol prep pads and swabs on January 11, 2011, the FDA issued a press release warning professionals about safe use of non-sterile prep pads.  The pads and swabs were said to have been contaminated with Bacillus cereus, a bacterium that can be very harmful to humans.  Read more on this press release at www.fda.gov/news.

Recalls:

Qualitest Pharmaceuticals Issues Voluntary, Nationwide Recall Of Hydrocodone Bitartrate And Acetaminophen Tablets, USP 10 MG / 500 MG, NDC 0603-3888-20, 60 Count, Lot Numbers T150G10B, T120J10E And T023M10A And Phenobarbital Tablets, USP 32.4 MG, NDC 0603-5166-32, 1000 Count, Lot Numbers T150G10B, T120J10E And T023M10A.
Reasons: Bottles may be incorrectly labeled.

American Regent Initiates Nationwide Voluntary Recall of Potassium Phosphates Injection, USP 15 mM/5 mL Phosphorus; 22 mEq/5 mL Potassium 5 mL Single Dose Vial, Lot# 0048
Reasons: Translucent Visible Particles.

American Regent Initiates Nationwide Voluntary Recall of Sodium Thiosulfate Injection, USP 10% (100 mg/mL) 10 mL Single Dose Vials Lot# 0056
Reasons: Translucent Visible Particles.

McNeil Consumer Healthcare Initiates Voluntary Recall Of Certain Over-The-Counter (OTC) Products
On January 14, 2011, McNeil Consumer Healthcare, a division of McNeil-PPC, voluntarily recalled certain lots and certain brands of Tylenol, Benadryl, Sudafed, and Sunutab.  The company initiated the recall as a precautionary measure after an extensive review of past production records showing insufficient or inadequate documentation of equipment cleaning records. www.fda.gov/recall

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