法规动态

FDA、EMA、TGA 及全球法规动态

#labeling error ×

2026年9月10日•1 分钟阅读

Stryker Issues Labeling Alert for T2 Alpha IMN Advanced Locking Screw Lot

Stryker reports a labeling error in one lot of T2 Alpha IMN advanced locking screws, which contain 75 mm screws instead of the specified 57.5 mm.

2026年8月30日•1 分钟阅读

Health Canada issues alert on Pro+ model p7924a13 labeling error

The UDI label for model p7924a13 incorrectly lists a 40‑inch surface, while the approved configuration is a 36‑inch surface, risking incompatibility with bed frames.

2026年8月24日•1 分钟阅读

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.

2026年8月23日•1 分钟阅读

Teva UK reports labeling error on Ponlimsi (Denosumab) 60mg carton

Teva UK Limited has identified a labeling mistake on the Ponlimsi (Denosumab) 60 mg pre‑filled syringe carton, which incorrectly states “For application to the skin” despite the product being licensed for subcutaneous injection.