Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma…
Reason Presence of Particulate Matter: Piece of metal found in a vial
164 recalls · Class III, newest first
Reason Presence of Particulate Matter: Piece of metal found in a vial
Reason Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
Reason Defective Container: Tube split from side seam
Reason Failed Tablet/Capsule Specification : Capsule breakage
Reason Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Reason Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Reason Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card.
Reason CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
Reason Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product…
Reason Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.
Reason Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container…
Reason Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability…