The U.S. Food and Drug Administration (FDA) has announced that a selection of the injectable drugs manufactured by Hospira, Inc., a Pfizer company, may be used passed the labeled expiration date to ease the ongoing critical shortage of critical care injectable drugs, including atropine, epinephrine and dextrose. More information on the specific lot numbers affected by this announcement is available here. For patient safety purposes, these drugs should continue to be stored as directed by their labels.

Meanwhile, the FDA also announced that Hospira is voluntarily recalling a number of other products because of sterility concerns, several of which are already in short supply. Among the recalled drugs facing shortages:   

• 8.4 percent sodium bicarbonate injection 50mL vials
• Neut (sodium bicarbonate 4 percent additive solution ) 5mL vials
• Potassium phosphates injection 45mM vials

Quelicin (succinylcholine chloride injection) 200 mg/10 mL vials, while not facing a shortage, are also part of the recalled products.

The FDA will continue to work with Pfizer to address the ongoing shortage of these essential drugs. The Agency will continue to permit the importation of Athenex’s sodium bicarbonate injectable. The FDA anticipates that additional supplies will be available from Athenex and continues to work to identify other potential sources of sodium bicarbonate. Efforts are also underway to identify additional sources of succinylcholine and potassium phosphate. Please continue to monitor the FDA’s updates regarding this situation.

Keywords: Drug Recalls, Epinephrine, Patient Safety, Pharmaceutical Preparations, Product Recalls and Withdrawals, Sodium Bicarbonate, Succinylcholine, United States Food and Drug Administration

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