Drugs@FDA Data Files

ABBOTT PARK, Ill., Nov. 24, 2025 — Abbott has initiated a medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the United States after internal testing determined that some sensors may provide incorrect low glucose readings.

The DSB is composed of representatives from two FDA Centers and eight other federal government agencies, the Agency for Healthcare Research and Quality, Centers for Disease Control and Prevention, Centers for Medicare and Medicaid Services, Department of Defense.

Endo, Inc. (OTCQX: NDOI) (“Endo”) announced today that one of its operating subsidiaries, Endo USA, Inc., is expanding its previously announced voluntary recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) due to potential product carton strength mislabeling.

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 06/09/2022
Short Title (70 char) BlendHouse. Reading, PA. EIR issued 06/09/2022
FEI Number 3015728839
Firm Name BlendHouse
Record Type EIR
State PA
Establishment Type Manufacturer

Category 2 of the Bulk Substances Nominated Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act

Unapproved New Drugs/Misbranded