RegulatoryOfficial

FDA roundup flags more Medline syringe recalls and Cronobacter alert on goat milk formula

🇺🇸 FDA CBER · Mon 09 Nov 2026

The agency's 4 June 2024 digest covers further recalls of China-made plastic syringes, a Cronobacter safety alert for an infant formula, and a CDER explainer on pharmaceutical quality.

The US Food and Drug Administration's at-a-glance news summary dated 4 June 2024 includes two safety-related items. The first is further recalls by Medline Industries LP, which markets and distributes plastic syringes made in China in the US. The firm initiated the recalls to stop use of affected products, which include bulk unauthorised plastic syringes made in China and bulk plastic syringes made in China that failed performance testing. The FDA said it will keep evaluating problems with syringes made in China and will update the public as new information emerges.

The second is a Safety Alert for Crecelac Infant Powdered Goat Milk Infant Formula, imported and distributed by Dairy Manufacturers Inc. The company had begun recalling several infant formula products on 24 May 2024 because they did not comply with all FDA infant formula regulations. The FDA issued the alert after new findings of Cronobacter contamination in a sample of the Crecelac product, and it is aimed at parents and caregivers.

The roundup also points to an FDA publication listing 10 things to know about the Center for Drug Evaluation and Research's pharmaceutical quality functions. The agency stresses that quality covers the manufacturing facilities and processes as well as the drug itself. Some of these functions apply before a prescription drug is approved. CDER also monitors marketed drugs and the facilities that make them to ensure continued quality.

A further item is an interview with Emer Cooke of the European Medicines Agency, published in the FDA's blog series From a Global Perspective. The FDA says it follows Commissioner Robert Califf's February trip to the EMA and the FDA-EU Bilateral held in Washington in April.

What it means for your team

  • Quality and supply-chain teams that handle plastic syringes made in China should check the full FDA announcements on the Medline recalls to see whether their stock is affected. The source does not list affected lots.
  • The syringe recalls cover both unauthorised products and products that failed performance testing, and the FDA says its evaluation of syringes made in China is continuing.
  • The roundup is a summary only. It gives no product details beyond those above, so teams should use the original FDA announcements for any compliance action.
  • The CDER explainer is a reminder that FDA oversight of quality extends to facilities and manufacturing processes, both before approval and after a product is marketed.

Official source: FDA CBER ↗

Article written by VigiEye from the official source (FDA CBER). AI-assisted; check the source before acting.

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