Actualizaciones regulatorias

The FDA’s ANDA 087722 for LORTAB (acetaminophen 500 mg/hydrocodone 5 mg oral tablet) includes a series of approved manufacturing and labeling submissions from 1984 to 1999; the product is now discontinued.

ICU Medical Canada is recalling IV sets with potential discoloration in the drip chamber; products remain usable per facility protocol.

Cynosure Lutronic reports patient burn incidents linked to spark and loud noise during DermaV laser vascular procedures.

ICU Medical Canada is recalling certain IV sets because discoloration may appear in the drip chamber, though they remain usable per protocol.

Cynosure Lutronic reports an adverse trend of spark and loud noise complaints causing patient burns during vascular treatments with the DermaV laser system.

FDA records show a series of approved labeling and manufacturing supplemental applications for the discontinued LINDANE 1% topical lotion under ANDA 087313.

The FDA record shows SCANDONEST L injectable, containing levonordefrin and mepivacaine, has a discontinued marketing status and a history of approved labeling and manufacturing submissions dating from 1984 to 2018.

The FDA’s ANDA088071 filing shows that DEXAIR ophthalmic ointment, containing 0.05% dexamethasone sodium phosphate, is marked discontinued by sponsor PharmaFair.

Health Canada reports failures in sterile barrier integrity testing for Maquet percutaneous insertion kits, limiting the FSCA to all PIK line products within shelf‑life.

Health Canada identified sterile barrier integrity failures in Maquet's percutaneous insertion kit and dilator sets, affecting all PIK line products within shelf-life.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) reports higher wear, corrosion and possible revision surgery risks for cobalt‑chrome modular neck hip stem components.

Unicycive is optimistic its third‑party manufacturing facility can meet FDA standards to support an approval, CEO Shalabh Gupta, M.D., said.