FDA Recall Notice 6/15/2017: Sodium bicarbonate/Succinylcholine Chloride/Potassium Phosphates

 

By David Showalter, PharmD, System Director, Pharmacy Services

 

S: On 06/15/17, Pfizer/Hospira issued a voluntary recall for 3 medications: Sodium bicarbonate vials, Succinylcholine Chloride vials, Potassium Phosphates vials.

 

B: The FDA communicated a voluntary recall from Pfizer/Hospira after contaminates were discovered during routine simulation testing of the manufacturing process. The recall involved several manufacturing lots of the medications that have the “potential” to contain microorganisms. However, at this time, there are no confirmed reports of contamination and Hospira has not received any safety alerts or adverse events with the recalled lots. They are asking healthcare professionals to report any suspected adverse events to the FDA.

 

Pfizer/Hospira has had ongoing issues with their compounding facilities which has been the primary reason for continuing drug shortages involving injectable electrolytes. One of the Hospira manufacturing plants was cited by the FDA in February 2017 following a June 2016 inspection that revealed noncompliance with several CGMP standards for finished pharmaceuticals. Manufacturing processes at this plant have been suspended pending corrective action and recertification by the FDA.

 

A: All 5 MLH pharmacy departments have completed a hospital wide review of inventory and we have quarantined the affected lots. We will ship the products back to Hospira/Pfizer when they issue a formal recall letter with return instructions.

 

A significant portion of our sodium bicarbonate vial inventory was depleted by this recall. We do have a limited supply of sodium bicarbonate syringes on hand and we will continue to judiciously manage our inventory.

 

Potassium phosphate inventory at MLH was also impacted but to a lesser extent as there is an alternate supplier. There was no impact on MLH succinylcholine inventory as our standard succinylcholine formulation is a compounded syringe from a different company.

 

R:  Medical staff need to be aware of the recall to appreciate the importance of reserving IV electrolytes for critical patients. The MLH pharmacy department issued an SBAR last month regarding IV electrolyte shortages and recommended conservation strategies.

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