Methylprednisolone Tablets
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container label instead of the correct expiration date of 02/2018.
14,801 recalls, newest first
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container label instead of the correct expiration date of 02/2018.
Reason Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.
Reason Subpotency: product assayed and found OOS for cyproheptadine
Reason Failed impurities/degradation: out of specification result for impurity secorapamycin.
Reason Crystallization; complaints received by the manufacturer of crystals forming in product
Reason Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
Reason Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
Reason CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
Reason Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.
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 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 Dissolution Specifications
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.