morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total…
Reason Lack Of Assurance Of Sterility.
11,815 recalls · Class II, newest first
Reason Lack Of Assurance Of Sterility.
Reason Lack Of Assurance Of Sterility.
Reason Lack Of Assurance Of Sterility.
Reason Lack Of Assurance Of Sterility.
Reason Lack Of Assurance Of Sterility.
Reason Lack Of Assurance Of Sterility.
Reason Superpotent drug: out of specification result for potency
Reason Presence of foreign substance (screw)
Reason Lack of Assurance of Sterility.
Reason Lack of Assurance of Sterility.
Reason Lack of Assurance of Sterility.
Reason Lack of Assurance of Sterility.
Reason Lack of Assurance of Sterility.
Reason Lack of Assurance of Sterility.
Reason Lack of Assurance of Sterility.
Reason Lack of Assurance of Sterility.
Reason Lack of Assurance of Sterility.
Reason Lack of Assurance of Sterility.
Reason Lack of Assurance of Sterility.
Reason Lack of Assurance of Sterility.
Reason Lack of Assurance of Sterility.
Reason Lack of Assurance of Sterility.
Reason Marketed Without an Approved NDA/ANDA
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
Reason Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.