Reason: Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Distributed: Hospitals, clinics, physicians, and patients in the Michigan area only.Reason: Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Distributed: Hospitals, clinics, physicians, and patients in the Michigan area only.Reason: Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Distributed: Hospitals, clinics, physicians, and patients in the Michigan area only.Reason: Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Distributed: Hospitals, clinics, physicians, and patients in the Michigan area only.Reason: Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Distributed: Nationwide and Puerto RicoReason: Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Distributed: Nationwide and Puerto RicoReason: Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter).
Distributed: Nationwide in the US and Puerto Rico.Reason: CGMP Deviations: The Active Pharmaceutical Ingredient was not manufactured according to current good manufacturing practices.
Distributed: MOReason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Distributed: NCReason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Distributed: NC