Nationwide Drug Shortages from Hospira Lack of Sterility Assurance

On June 27, 2017, PharMEDium Services became the latest drug manufacturer or compounder to recall products due to Hospira’s June 15, 2017, recall. Fagron Sterile Services, Advanced Pharma, and Alvogen previously recalled products because the products contained material subject to Hospira’s recall. This cascade of recalls has increased the severity of a nationwide shortage of injection vials of sodium bicarbonate; Neut, a sodium bicarbonate additive solution; and potassium phosphates.


On June 15, 2017, Hospira, Inc., a Pfizer company, recalled 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 due to microbial growth detected during a routine simulation of the manufacturing process, which indicated the introduction of microorganisms into the products.


The 42 lots recalled by Hospira were distributed nationwide to wholesalers and hospitals from January to June 2017 in the U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore.


Sodium Bicarbonate Injection, USP, is indicated in the treatment of metabolic acidosis, certain drug intoxications, poisoning by salicylates or methyl alcohol, and certain hemolytic reactions. Sodium bicarbonate is also used to treat severe diarrhea, which is often accompanied by significant loss of bicarbonate.


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.


Potassium Phosphates Injection, USP 3 mM P/mL, is added 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.


The products recalled by PharMEDium Services were compounded using certain Hospira products. PharMEDium Services recalled specific lots of Potassium Phosphate and Succinylcholine Chloride.


On June 15, 2017, Alvogen recalled seven lots of Clindamycin Injection USP ADD-Vantage Vials, which were distributed nationwide in the U.S. to wholesalers and hospitals between May 2016 and June 2017. The recalled Clindamycin Injection was manufactured for Alvogen by Hospira. Clindamycin Injection is indicated in the treatment of serious infections caused by susceptible bacteria. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate.


On June 22, 2017, Advanced Pharma, Inc. d/b/a Avella of Houston, recalled specific lots of Potassium Phosphate and Succinylcholine Chloride. The recalled products were repackaged and/or compounded at its Houston, Texas facility using certain Hospira products.


On June 23, 2017, Fagron Sterile Services recalled three lots of Succinylcholine Chloride 20mg/mL 5mL syringe. This product was manufactured by Hospira and repacked by Fagron Sterile Services.


Per Hospira, in the event that a recalled 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.


See the FDA Safety Alert for PharMEDium Services


See the Recall for PharMEDium Services


See the FDA Safety Alert for Fagron Sterile Services


See the FDA Safety Alert for Advanced Pharma


See the FDA Safety Alert for Alvogen


See the FDA Safety Alert for Hospira


See the Recall for Hospira


See the FDA Drug Safety and Availability Announcement


See also Medical Law Perspectives Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication