Pfizer recalls injectables made at Rocky Mount over potential contamination risk
The recalled products include 42 lots of 8.4% Sodium Bicarbonate Injection, 5 lots of Neut, 5 lots of Quelicin and 7 lots of Potassium Phosphates Injection distributed in the US, the Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore since January.
The US drug manufacturer said the move was prompted by the detection of microbial growth during a "routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.”
A Pfizer spokeswoman told us "No batches of distributed product have been identified as actually containing microorganisms" adding that "the potentially impacted product lots were manufactured at the Rocky Mount, NC [facility]."
She also said: "An investigation has been initiated to determine the root cause and corrective and preventive actions. Pfizer is working diligently to restore supply of these products and is in communication with the FDA Drug Shortage staff to address any supply issues.
Sodium bicarbonate shortage
Sodium bicarbonate – which is used in a variety of pharmaceutical and paramedical applications such as haemodialysis as well as the treatment of metabolic acidosis and salicylate poisoning – is already in short supply.
In May, Pfizer told the US Food and Drug Administration (FDA) issues relating to “manufacturing, distribution, and third-party supplier delays” meant that supplies of sodium bicarbonate and a number of other injectables would be limited.
On Saturday, Canadian regulator Health Canada reported that sodium bibacrobate injection is in short supply citing both the recall and the earlier manufacturing delays.
Rocky history
A number of products made at Rocky Mount have been recalled over the past few years.
In 2013, Hospira withdrew lots of sodium chloride and diazepam made at the site after customers found particulate matter in the products. In August 2016, the firm pulled a batch of bupivacaine hydrochloride injection after a customer complaint.
Historically, the facility has also been the subject of criticism.
The problems began in 2010 when the US Food and Drug Administration (FDA) warned Hospira about manufacturing operations.
Hospira spent the next few years addressing issues raised by the FDA and – in 2014 – the Rocky Mount facility passed an inspection with no observations. A year later the firm told us the FDA had “closed out” the 2010 warning letter.
