Actualizaciones regulatorias

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.

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.

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.

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.