THE DRUG DOCKETThe FDA logged a Class I recall of 35,883 boxes of the simethicone antigas product on 17 June, after softgels were contaminated with a propylene glycol-based coolant that leaked from packaging machinery.
3 min read
THE DRUG DOCKETThe FDA logged the recall of 145,464 bags of 0.9% sodium chloride in 500 mL Viaflex containers on 9 September, after fiberglass particulate matter was found. It is the agency's most serious recall tier.
3 min read
THE DRUG DOCKETThe Class I recall covers 625,500 prefilled syringes. Cartons labelled morphine sulfate 2 mg/mL hold a Dilaudid (hydromorphone) syringe of 0.5 mg/0.5 mL instead — the wrong opioid at the wrong dose.
3 min read
THE DRUG DOCKETThe FDA classified the nationwide recall Class I, its most serious tier. About 31,935 multi-dose vials are affected, with particulate identified as nylon, glass and other materials, plus broken and leaking units.
3 min read
Products reached 99 countries before recalls began. WHO's first Disease Outbreak News report on the event lists 144 suspected and confirmed illnesses and calls the risk moderate.
3 min read