Hospira announces a nationwide recall of one lot of Lactated Ringer’s and 5% Dextrose Injection due to leakage and contamination. According to reports that surfaced in last few days the step was taken due to appearance of spore-like structured particulate, consistent with mold in the solution after a leakage on the main container of the solution.

Lactated Ringer’s and 5% Dextrose Injection, USP is a sterile, non-pyrogenic solution which is indicated as a source of electrolytes, water, calories or as an alkalinizing agent. Each 100 mL of the solution contains 5 g Dextrose Hydrous, 600 mg Sodium Chloride, 310 mg Sdium Lactate (C3H5NaO3), 20 mg of Calcium Chloride, 30 mg of Potassium Chloride. The formulation is devoid of any kind of anti-microbial agents. The solution is present in a plastic container which can leak out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million.

According to experts, when a primary container with an overwrap has a leak, it offers an open pathway that could facilitate contamination. Since the overwrap is not sterile and chances are that leaked fluid gets trapped in that space and it has the potential to get back into the main container. In such a situation solution could be contaminated with mold.

If such contaminated formulation and solutions are given to patients the mold present in the solution could lead to infections in blood stream which ultimately could lead to septic shock. Some of the symptoms and signs of this shock includes:

  • Fever
  • Fast heart rate
  • Shortness of breath
  • Nausea
  • Vomiting

Some Precautions while using this solution:

  • Patients with severe renal insufficiency, congestive heart failure should use this solution with great caution
  • Lactated Ringer’s and 5% Dextrose Injection, USP should be used with great care, in patients with hyperkalemia
  • The solution should be administered consciously in people who are suffering from hepatic insufficiency

The infected lot was distributed between the dates of January 2012 and June 2012 across the United States. Though, the company has said that it has not received any reports of adverse effects associated with the solution and the recall is being made as a precautionary measure. Meanwhile FDA has announced that people having solutions from the affected lot should stop using it.

For people having any enquiry can call 1-800-615-0187, 24×7. The manufacturer will make available every facility to arrange for the return of the product. People can also download a reporting form, complete it and submit the report Online at www.fda.gov/MedWatch/report.htm or fax it to 1-800-FDA-0178

Meanwhile, the manufacturer has sought co-operation of people and clinicians to avoid further worsening of the matter and has reiterated that consumer satisfaction is at the top of their priority.