24 recalls · Class II, newest first
Reason STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source…
Reason Lack of assurance of sterility.
Reason Failed pH Specifications
Reason Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Reason Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Reason Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Reason Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond…
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Reason CGMP deviation: product released prior to supplier approval.
Reason Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of…
Reason Mislabeling: preservative free product labeled as preserved.
Reason Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Reason CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Reason Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Reason Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Reason Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a…
Reason Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the…
Reason Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the…