Two companies that have fallen under the shadow of FDA inspectors in the last year initiated product recalls this week.
CSL Biotherapies ($CSL.AX) is recalling 6 batches of Albumex after tests showed some of it is contaminated with low levels of ethylene glycol. In a separate incident, Hospira ($HSP) is recalling syringes because some were believed overfilled.
The Australian Therapeutic Goods Administration (TGA) in March quarantined 96 batches of the CSL product to investigate ethylene glycol contamination. The organic compound, which is commonly associated with antifreeze, has medical uses. It can cause poisoning in high enough doses.
In an announcement Wednesday, the TGA says of those 96, 18 batches have low levels of ethylene glycol. Most of those have already been quarantined at hospitals or warehouses, but 5 that had already been exported are being recalled.
Hospira began a recall of one lot of morphine sulphate injection after a customer reported discovering syringes containing more than 1 ml. Hospira distributed the lot, each box of which contains 10 prefilled cartridges, to "a limited number of hospitals" in 10 states, in-Pharma Technologist reports. The FDA alert says the affected lot was distributed in January but that Hospira has not received any reports of adverse events related to the problem.
Both companies have had run-ins with the FDA over lapses in their manufacturing quality. Flu vaccine maker CSL was cited by the FDA in June for a lack of follow-through on raw material test failures to half-hearted investigations into adverse reactions suffered by hundreds of Australian children after they received the Fluvax shot last year. Twenty-three of those children landed in the hospital with seizures and fever. The Australian government ultimately withdrew the flu vaccine for use in children.
The company has been working through manufacturing issues at plants in Austin, TX, and Rocky Mount, NC. The North Carolina facility was closed in December after quality issues were raised by the FDA but resumed production in January after the company threw extensive resources at fixing problems. It expects the plant to hit 60% to 70% production capacity by year's end.
The company has been adding a slew of new people to its manufacturing and quality control ranks. Just this week it named industry veteran John B. Elliott senior vice president of operations. He will have responsibility for Hospira's global operations organization.