Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69389-06229
US Specialty Formulations
Lack of Assurance of Sterility
95,018 total recalls in our database
US Specialty Formulations
Lack of Assurance of Sterility
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Grato Holdings
Microbial contamination of non-sterile product.
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
The endoscope may experience a loss of image when activating monopolar electrocautery, due a manufacturing assembly process issue.
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
Siemens Healthcare Diagnostics
Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results
New Standard Device
1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The increased wire diameter and new manufacturing process are meant to provide a stronger wire and reduced breakage.