Lack of Assurance of Sterility
All Recalls
95,114 total recalls in our database
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manufactured by: Rubicon Research Private Limited, Ambernath Dist Thane 421506 India, NDC 52817-360-00
Rubicon Research Private Limited
Presence of Foreign Substance: metal in tablet
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Out of Specification for active ingredient
Out of Specification for active ingredient
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Out of Specification for active ingredient
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-688-52
Dr. Reddy's Laboratories
Lack of Assurance of Sterility: Leaking vials
Lack of Assurance of Sterility
BD Pyxis(TM) Anesthesia Station 4000, REF: 338
CareFusion 303
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junction or the upper esophageal sphincter between the pharynx and the esophagus, which is the narrowest part of the alimentary canal.
Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment
Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1.100.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.