Hospira initiated the recall one lot of 0.25% bupivacaine hydrochloride injection, USP (NDC: 0409-1159-02, Lot 59-064- DK, Expiry 1NOV2017) on August 5, explaining that the precautionary measure was prompted by a compliant.
A Pfizer spokesman told us the recalled production – which is used as a local anaesthetic in surgery and dental procedures – was made at the Hospira manufacturing facility in Rocky Mount, North Carolina.
Hospira said it has staretd an investigation to determine the root cause and plans to implement corrective and preventive actions.
A number of products made the 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.
Historically, the facility has also been the subject of regulatory criticism. The problems began in 2010 when the US Food and Drug Administration (FDA) warned Hospira about manufacturing operations at the plant.
Hospira spent the next few years address issued 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.