1,709 recalls · Class III, newest first
Reason Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.
Reason Crystallization; Complaints that cream appears to have crystallized
Reason Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.
Reason Labeling: Incorrect or Missing Package Insert
Reason Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.
Reason Failed Impurities/Degradation Specification; 9 month stability
Reason Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.
Reason Failed Tablet/Capsule Specifications
Reason cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration
Reason Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Reason Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Reason Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Reason Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Reason Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Reason Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Reason Defective delivery system: Softgel capsules are leaking.
Reason Lack of Assurance of Sterility
Reason Chemical Contamination: Bottles may contain broken dessicants
Reason Discoloration: presence of scuffing marks on tablets.
Reason Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Reason Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Reason Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.
Reason Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability testing at the 18th month interval for the Famotidine 10 mg Tablet, USP.
Reason Labeling: Not elsewhere classified - count on the label was incorrect.
Reason Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.