16 FDA recalls mention Urea. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Urea.
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
Reason Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Reason Crystallization; complaints received by the manufacturer of crystals forming in product
Reason Crystallization; Complaints that cream appears to have crystallized
Reason Lack of Processing Controls
Reason Lack of Processing Controls
Reason Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Reason Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Reason Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
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