How many times has Hospira, now owned by Pfizer, recalled some form of dextrose in the last four years? Twenty-three times, roughly one recall every two months on average. But its latest recall of 25% dextrose injection is different because this product is for infants.
The company began the voluntary class I recall of one lot of 25% dextrose in single 10-ml syringes injection in April, according to a letter sent to customers. The FDA gave it a classification last week. The company said the syringes are indicated for neonates or older infants to restore depressed blood glucose values and control symptoms.
The company initiated the recall of the 71,550 syringes after a customer complained of discovering particulate matter within an internal sample syringe, which Pfizer said turned out to be a human hair. The company said the risk of an adverse event is low, and it has not received any reports. It pointed out, however, that with particulate in injections there are risks that run from local swelling through the possibility for an embolism or coronary infarction.
The dextrose for infants is among eight Pfizer products in 24 dose forms that the company informed customers last month are in short supply. Also in short supply are different presentations of Bicillin, labetalol hydrochloride, sodium acetate, calcium chloride, atropine sulfate and epinephrine. The company said it expects to resolve the supply interruption of the infant dose of dextrose by August.
The letter told clients that the causes of individual shortages vary, but the majority are due to three main factors: manufacturing, distribution, and third-party supplier delays.
Pfizer said it has a “dedicated team focused on addressing these delays” and has taken eight steps to speed the recovery of supplies, including allocating some medicines to minimize stockouts, increasing production at key injectable plants and qualifying alternative third-party suppliers who meet the company’s standards.