TriMix MEDIUM (Papaverine HCL 21 mg/mL Phentolamine Mesylate 0.7 mg/mL Alprostadil 7 mcg/mL), 2 mL multidose MDV Inj. Compounded…
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.
12 FDA recalls mention Shea. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Shea.
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.
Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Reason Microbial Contamination of Non-Sterile Products: Consumer complaint and subsequent testing found lot to be out of specification for mold.
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