Medline widens syringe recalls as FDA keeps probing Chinese-made devices

Medline Industries LP has pulled more imported plastic syringes from the US market, according to an FDA news digest dated 4 June 2024. The company markets and distributes the Chinese-manufactured devices. The agency says Medline started the recalls to stop affected products being used.

The recalls cover two categories: bulk syringes lacking authorisation, and bulk syringes that did not pass performance checks. The digest does not name lots, quantities or customers, and it gives no indication of the financial impact on Medline or its buyers. The FDA says it will keep assessing problems with syringes made in China and will update the public when it learns more.

The same digest carries a safety alert for Crecelac Infant Powdered Goat Milk Infant Formula, which Dairy Manufacturers Inc. imports and distributes. The company began recalling several infant formula products on 24 May 2024 because they did not meet all FDA infant formula rules. The agency issued its alert after new tests found Cronobacter in a sample of the Crecelac product. The alert is addressed to parents and caregivers.

Two other items are less tied to commercial events. One is a CDER list of 10 points on its pharmaceutical quality work. It says quality covers manufacturing sites and processes as well as the drug itself, and that some checks come before approval while CDER also monitors marketed drugs and their facilities. The other is an interview with the European Medicines Agency's Emer Cooke, which the FDA links to Commissioner Robert Califf's February visit to the EMA and an FDA-EU Bilateral held in Washington in April.