The Fagron recall covers lots of the general anaesthetic succinylcholine chloride supplied to hospitals and surgical clinics in the US.
Advanced Pharma has pulled lots of Pfizer-made potassium phosphate and succinylcholine chloride that were compounded at its plant in Houston, Texas.
Both firms cited the detection of microbial growth during a simulation of the manufacturing process conducted by Hospira – a division of Pfizer – as the driver for the recalls.
In an echo of Pfizer’s statement, Fagron said: “The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated. No microorganisms have been confirmed in any Fagron Sterile Services lot.”
Pfizer recalled four injectables made at the facility after identifying the potential contamination risk during routine testing.
The recalled products include 42 lots of 8.4% Sodium Bicarbonate Injection, 5 lots of Neut, 5 lots of Quelicin (succinylcholine chloride) and 7 lots of Potassium Phosphates Injection distributed in the US, the Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore since January.
Unlike some of the drugs recalled by Pfizer, there is no shortage of succinylcholine chloride in the US.
Last Friday, the US Food and Drug Administration (FDA) announced that, based on stability data provided by Pfizer, the use by dates for some lots of the products that have already been shipped have been extended.