Class II · Moderate risk
Arthrotec 75
Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Murocel (methylcellulose)
Lack of Assurance of Sterility: Bausch & Lomb, Inc. is recalling 7 Lots of Murocel Methylcellulose Lubricant Opthalmic Solution 1% (15 mL). Product was found to be OOS for Antimicrobial Effectiveness testing (AET) at the 12 month stability time point.
Class II · Moderate risk
Daytrana (methylphenidate)
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Class II · Moderate risk
Daytrana (methylphenidate)
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Class II · Moderate risk
Daytrana (methylphenidate)
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Class II · Moderate risk
Daytrana (methylphenidate)
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Class II · Moderate risk
Albuterol Sulfate Inhalation Solution
Lack of Assurance of Sterility
Class II · Moderate risk
ANIRACETAM FAST ACTING NOOTROPIC Dietary Supplement…
Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug.
Class II · Moderate risk
PIRACETAM POWDER COGNITION ENHANCING AGENT Dietary Supplement CTD…
Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug.
Class II · Moderate risk
PIRACETAM COGNITION ENHANCING AGENT Dietary Supplement…
Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug.
Class II · Moderate risk
Metronidazole Tablets
Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.
Class II · Moderate risk
Xactdose Phenytoin Oral Suspension
Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume
Class II · Moderate risk
Methylprednisolone Tablets
Impurities/Degradation Products; Product is being recalled due to the potential of not meeting the Impurity C specification through the product shelf life
Class II · Moderate risk
Concentrated Sodium Chloride Injection
Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.
Class II · Moderate risk
Procrit (epoetin alfa)
Presence of Particulate Matter: glass delamination
Class II · Moderate risk
Eye Drops advanced relief
Labeling: Label Mix-Up: Incorrect back labeling of the immediate container of eye drops (unit carton and front label are correct) which do not list three active ingredients: Dextran 70, PEG 400, and povidone.
Class II · Moderate risk
Leflunomide tablets
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Class II · Moderate risk
Leflunomide tablets
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.