규제 업데이트
2026년 8월 30일•1분 읽기
Stryker Issues Recall of StrykeFlow PS Handpiece Over Leak Complaints
Cardinal Health reports a Stryker recall of the StrykeFlow PS device due to multiple complaints of handpiece leakage during use.
규제 업데이트
2026년 8월 30일•1분 읽기
Apotex Apo‑Semaglutide Injection Recall Due to Incorrect Dose Display
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.
규제 업데이트
2026년 8월 29일•1분 읽기
Health Canada alerts KPC contamination in BIOFIRE diagnostic panels
Health Canada reports elevated KPC false‑positive rates in BIOFIRE FilmArray Pneumonia and Joint Infection panels due to contamination in the outer primer pellet.
규제 업데이트
2026년 8월 26일•1분 읽기
Health Canada recalls Twins Herbal liquids Idakole and Pelorie for undeclared sildenafil
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.
규제 업데이트
2026년 8월 25일•1분 읽기
FDA Recall D-0296-2023 Issued Over Lack of Sterility Assurance
The FDA has initiated recall D-0296-2023 because the affected product failed to meet sterility assurance requirements.
규제 업데이트
2026년 8월 25일•1분 읽기
FDA Recalls Products Over Incorrect or Missing Lot and Expiration Dates
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.
규제 업데이트
2026년 8월 25일•1분 읽기
FDA Recalls Drug Over Adulterated API and Content Uniformity Failure
The FDA has recalled a product after discovering an adulterated active ingredient and insufficient manufacturing controls that caused content uniformity failures.
규제 업데이트
2026년 8월 25일•1분 읽기
FDA Recall: Products Exposed to Improper Temperatures (D-0179-2024)
The FDA has recalled products after CGMP deviations revealed exposure to temperatures outside labeled storage conditions.
규제 업데이트
2026년 8월 24일•1분 읽기
FDA Identifies GMP Violations Affecting Sterility Assurance
An FDA inspection uncovered GMP violations that may compromise product sterility and quality, prompting a recall.
규제 업데이트
2026년 8월 24일•1분 읽기
FDA Recall: CGMP Deviations Due to Intermittent Temperature Excursions
The FDA has issued a recall citing CGMP deviations caused by intermittent temperature excursions during storage.
규제 업데이트
2026년 8월 24일•1분 읽기
Label Mix-up: Amantadine Capsules Contain Cyclobenzaprine Tablets
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.
규제 업데이트
2026년 8월 24일•1분 읽기
Recall: Ifosfamide IV Vials Not Refrigerated at Amerisource Bergen Distribution Centers
Certain vials of Ifosfamide IV were found to have been stored without refrigeration at Amerisource Bergen distribution centers, prompting a recall.