Hospira issues a voluntary nationwide recall for 8.4% Sodium Bicarbonate Injection, USP, Neut (Sodium Bicarbonate 4% Additive Solution), QUELICIN (Succinylcholine Chloride Injection, USP) and Potassium Phosphates Injection, USP due to a potential for lack of sterility assurance.
Hospira, Inc., a Pfizer company, is voluntarily recalling 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials, 5 lots of Neut (Sodium Bicarbonate 4% additive solution) 5 mL vials, 5 lots of Quelicin (Succinylcholine Chloride Injection, USP) 200 mg/10 mL vials, and 7 lots of Potassium Phosphates Injection, USP, 45 mM vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
In the event that impacted product is administered to a patient, there is a reasonable probability that the patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis. The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated. No batches of distributed product have been identified as actually containing microorganisms.
To date, Hospira has not received reports of any adverse events associated with this issue. Hospira places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process.
Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis; in the treatment of certain drug intoxications, in poisoning by salicylates or methyl alcohol, and in certain hemolytic reactions.
Sodium bicarbonate is indicated in severe diarrhea, which is often accompanied by significant loss of bicarbonate.
Neut (4% sodium bicarbonate additive solution) is indicated for use as an additive to raise the pH of acid solutions administered intravenously to reduce the incidence of chemical phlebitis and patient discomfort due to vein irritation at or near the site of infusion.
Quelicin (Succinylcholine Chloride Injection, USP) is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation; and Potassium Phosphates Injection, USP 3 mM P/mL (millimoles/mL) is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake.
It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.i See Appendix for lots and packaging information.
These lots were distributed nationwide in the U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore to wholesalers and hospitals from January to June 2017. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.
Pfizer is working to restore supply of these products and is in communication with the FDA to address any supply issues.
Hospira will be notifying its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle in the United States. For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.
For clinical inquiries, please contact Hospira using the information provided below.
|Hospira Contact||Contact Information||Areas of Support|
|Pfizer Complaint Management||1-800-438-1985 (24 hours a day 7 days per week)||To report adverse events or product complaints|
|Pfizer Medical Information||1-800-615-0187 (8am to 7pm EST Monday through Friday)||Medical inquiries|
This recall is being executed with the knowledge of the U.S. Food and Drug Administration.
(Source: U.S. Food and Drug Administration)