This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
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Tandem Diabetes Care Issues Voluntary Medical Device Correction for Select t:slim X2 Insulin Pumps
SAN DIEGO – August 7, 2025 – Tandem Diabetes Care, Inc. (Nasdaq: TNDM) has announced a voluntary medical device correction for select t:slim X2 insulin pumps to address a potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery.Drug Compliance Programs
FDA compliance programs provide guidance and instructions to FDA staff for obtaining information to help fulfill agency plans in the specified program area.Dr. Reddy’s Laboratories, Mirfield, West Yorkshire, UK 9.1-9.5.25_483
Record Date: 09/05/2025
Entity Name: Dr. Reddy’s Laboratories (EU) Ltd.
FEI Number: 3002807544
Record Type: 483
Country: United Kingdom
Establishment Type: API ManufacturerPresident’s Emergency Plan for AIDS Relief (PEPFAR)
Presidential Emergency Plan for AIDS Relief contentGuangdong Renhe Guozhuang Biotechnology Co., Ltd. – 719045 – 12/16/2025
CGMP/Finished Pharmaceuticals/Adulteratedwww.d-pharmacy.com – 711075 – 07/16/2025
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