BiMix Phentolamine/Papaverine 2 mg/30 mg/mL
Lack of Assurance of Sterility
2,357 recalls · Class II, newest first
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Marketed Without An Approved NDA/ANDA: Contains an unapproved drug, ligandrol LGD-4033
cGMP Deviations; product does not comply with cGMP requirements
cGMP Deviations; product does not comply with cGMP requirements
cGMP Deviations; product does not comply with cGMP requirements
cGMP Deviations; product does not comply with cGMP requirements
cGMP Deviations; product does not comply with cGMP requirements
cGMP Deviations; product does not comply with cGMP requirements
cGMP Deviations; product does not comply with cGMP requirements
cGMP Deviations; product does not comply with cGMP requirements
cGMP Deviations; product does not comply with cGMP requirements
cGMP Deviations; product does not comply with cGMP requirements
Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.
Crystallization; identified as calcium salt of Ketorolac
Crystallization; identified as calcium salt of Ketorolac
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.
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.
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.