HCG Reconstitued 50,000 IU Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1736-50
Pharm D Solutions
Lack of Assurance of Sterility
95,064 total recalls in our database
Pharm D Solutions
Lack of Assurance of Sterility
Pharm D Solutions
Lack of Assurance of Sterility
Pharm D Solutions
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Pharm D Solutions
Lack of Assurance of Sterility
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Pharm D Solutions
Lack of Assurance of Sterility
Pharm D Solutions
Lack of Assurance of Sterility
Pharm D Solutions
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Pharm D Solutions
Lack of Assurance of Sterility
Pharm D Solutions
Lack of Assurance of Sterility
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Pharm D Solutions
Lack of Assurance of Sterility
Pharm D Solutions
Lack of Assurance of Sterility
Pharm D Solutions
Lack of Assurance of Sterility
Pharm D Solutions
Lack of Assurance of Sterility
Pharm D Solutions
Lack of Assurance of Sterility
It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.
Cook Medical Incorporated
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.