The recalled lot of morphine sulfate 0.5mg/mL - E52418EV11C and NDC 45183-0322-78 – was made at Pharmakon’s facility in Noblesville, Indiana on February 3 and shipped to hospitals in Indiana and Illinois.
Pharmakon withdrew the drug on February 11 after lab tests indicated it was “super-potent.”
Five days later the firm reported “adverse events in three infants associated with the use of the recalled morphine” to the Food and Drug Administration (FDA).
The Noblesville site is registered as an “outsourcing” facility under the 2013 Drug Quality and Safety Act (DQSA), which means it must comply with current good manufacturing practices (cGMP) standards and is subject to inspection by the FDA.
The FDA has already conducted two inspecitons.
Agency teams visited Noblesville in April 2014 after receiving reports of a number of adverse events associated with a batch of the anesthesia drug midazolam that have been produced at the site.
A warning letter issued a year later the FDA indicated that corrective actions implements by Pharmakon had not sufficient and gave the compounder 15 days to bring operations up to code.
Compound interest
The US FDA has been casting a closer eye over manufacturing operations at compounding pharmacies for the past few years following a number of contamination and quality-related problems.
Compounding pharmacy has a complex history. In the 1990s the FDA could identify drugs for which compounding posed a threat to their efficacy or safety. However, in 2001 the agency was stripped of these powers after they the US Supreme Court ruled them unconstitutional.
Since the ruling – which prompted the dissolution of the FDA's Pharmacy Compounding Advisory Committee – regulatory monitoring of compounders was sketchy at best with the FDA becoming involved in various legal battles with firms it tried to regulate.
The situation changed dramatically in 2012 when an outbreak of fungal meningitis was linked to a compounding pharmacy that resulted – in 2013 – of the FDA being granted powers to inspect both pharmacies and facilities that register as outsourcing sites.