Class III · Low risk
Tranexamic Acid USP Tablets
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
FDA Drug Recalls
170 recalls · Class III, newest first
Class III · Low risk
Lidocaine Patch 5%
Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.
Class III · Low risk
Epinephrine Professional EMS
Labeling; Incorrect NDC number on outer carton of product.
Class III · Low risk
MEKTOVI (binimetinib)
Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.
Class III · Low risk
Evamist (estradiol transdermal spray)
Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.
Class III · Low risk
Atropine Sulfate Ophthalmic Solution
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Class III · Low risk
Tranexamic Acid Injection
Presence of Particulate Matter: Piece of metal found in a vial
Class III · Low risk
Timolol Maleate Ophthalmic Solution
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
Class III · Low risk
Tacrolimus Ointment
Defective Container: Tube split from side seam
Class III · Low risk
Aspirin and Extended-Release Dipyridamole Capsules
Failed Tablet/Capsule Specification : Capsule breakage
Class III · Low risk
Butalbital
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Class III · Low risk
Butalbital
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Class III · Low risk
Distributed by: DocRx
Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card.
Class III · Low risk
Ranitidine Tablets USP
CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
Class III · Low risk
INOVA (benzoyl peroxide)
Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.
Class III · Low risk
Ramipril Capsules
Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.
Class III · Low risk
Magnesium Sulfate Inj.
Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
Class III · Low risk
Quelicin (Succinylcholine Chloride)
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 on the glass vial.
Class III · Low risk
Normosol-M and 5% Dextrose
Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".
Class III · Low risk
Amidate (Etomidate Injection, USP)
Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.