Regulatory Updates

Cardinal Health reports a Stryker recall of the StrykeFlow PS device due to multiple complaints of handpiece leakage during use.

Apotex Inc. has recalled lot 700059A of its Apo‑Semaglutide 2 mg pen after the dose window may incorrectly show a 2 mg dose, delivering 2 mg instead of the intended 0.25 mg or 0.5 mg.

Health Canada reports elevated KPC false‑positive rates in BIOFIRE FilmArray Pneumonia and Joint Infection panels due to contamination in the outer primer pellet.

Health Canada has issued a recall of Twins Herbal’s Idakole and Pelorie liquid products, which were sold without market authorization and contain the undeclared prescription drug sildenafil. Consumers should stop use and contact a healthcare provider.

The FDA has initiated recall D-0296-2023 because the affected product failed to meet sterility assurance requirements.

The FDA has issued a recall for products with labeling errors, specifically incorrect or missing lot numbers and expiration dates that exceed the Beyond Use Date of at least one ingredient.

The FDA has recalled a product after discovering an adulterated active ingredient and insufficient manufacturing controls that caused content uniformity failures.

The FDA has recalled products after CGMP deviations revealed exposure to temperatures outside labeled storage conditions.

An FDA inspection uncovered GMP violations that may compromise product sterility and quality, prompting a recall.

The FDA has issued a recall citing CGMP deviations caused by intermittent temperature excursions during storage.

FDA recall (D-1035-2017) reports cartons labeled as Amantadine HCl 100 mg capsules actually contain Cyclobenzaprine HCl 5 mg tablets due to a labeling error.

Certain vials of Ifosfamide IV were found to have been stored without refrigeration at Amerisource Bergen distribution centers, prompting a recall.