Recalls for 06/01/2020

Epinephrine Auto-Injector Devices by Amneal and Impax: CDER Alert - FDA Alerts Patients and Health Care Professionals About Device Malfunction
06/01/2020 Medical Recall

FDA is alerting the public to immediately inspect certain lots of Amneal and Impax epinephrine auto-injector 0.3 mg to ensure the yellow “stop collar” in the device is present.

The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication
06/01/2020 Medical Recall

FDA announces BIOCELL Textured Surface Allergan Breast Implants and Tissue Expanders Will No Longer Be Sold in the U.S.

Medtronic recalls StealthStation auto-registration feature due to inaccuracies during deep brain stimulation (DBS) procedures
06/01/2020 Medical Recall

StealthStation auto-registration feature helps guide surgeons to conduct deep brain stimulation (DBS) procedures. A software issue may lead surgeons to erroneously perform DBS procedures.

Amneal Pharmaceuticals LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, Due to Detection of N-Nitrosodimethylamine (NDMA) Impurity
06/01/2020 Medical Recall

Amneal Pharmaceuticals LLC Bridgewater, New Jersey (Amneal), is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, within expiry to the Retail Level.
Amneal was notified by the U.S. FDA that the Agency’s testing of seven lots of Metformin Hydr

Allergan Aesthetics Launches Dedicated Multi-Channel Campaign to Contact Patients Who May Not Be Aware of The Biocell® Recall
06/01/2020 Medical Recall

Allergan Aesthetics, an AbbVie company (NYSE: ABBV), is initiating a new digital campaign to improve device tracking and further identify and reach breast implant patients who have, or have had, BIOCELL® breast implants and/or tissue expanders to inform them of the risk of BIA-ALCL. Since Jul