Akorn Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine recall — FDA D-1089-2017
Crystallization with subpotent out of specification assay results for chlorhexidine.
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
Crystallization with subpotent out of specification assay results for chlorhexidine.
Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.
Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Insufficient documentation to support product sterility claims.
Devices are not consistent with Quality System Requirements.
Devices are not consistent with Quality System Requirements.
Devices are not consistent with Quality System Requirements.
Devices are not consistent with Quality System Requirements.
Devices are not consistent with Quality System Requirements.
Devices are not consistent with Quality System Requirements.
Devices are not consistent with Quality System Requirements.
Insufficient documentation to support product sterility claims.
Insufficient documentation to support product sterility claims.
Devices are not consistent with Quality System Requirements.
Devices are not consistent with Quality System Requirements.
Devices are not consistent with Quality System Requirements.
Devices are not consistent with Quality System Requirements.
Devices are not consistent with Quality System Requirements.
Insufficient documentation to support product sterility claims.
Insufficient documentation to support product sterility claims.
Devices are not consistent with Quality System Requirements.
Devices are not consistent with Quality System Requirements.
Browse recent months with enough recall history for useful comparison.