Class II · Moderate risk
Nisoldipine Extended Release Tablets
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,535 recalls, newest first.
Class II · Moderate risk
Thyro-Tab.075 mg.
Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval.
Class II · Moderate risk
Levothroid
Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval.
Class II · Moderate risk
Physicians Total Care
Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.
Class II · Moderate risk
Physicians Total Care
Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.
Class II · Moderate risk
Lipitor (Atorvastatin calcium)
Chemical Contamination: Complaints of an uncharacteristic odor identified as 2,4,6 tribromoanisole.
Class II · Moderate risk
Eloxatin (OXALIplatin injection)
CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.
Class II · Moderate risk
Eloxatin (OXALIplatin injection)
CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.
Class II · Moderate risk
Levothroid
Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval.
Class II · Moderate risk
Thyro-Tab 0.050mg.
Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval.
Class II · Moderate risk
Hipoglos Ointment
Misbranded
Class II · Moderate risk
ChloraPrep with Tint
Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.
Class II · Moderate risk
Prefera OB One Gel Capsules
Labeling: Presence of Undeclared Color Additive; The product is being recalled because several inactive ingredients were not included in the labeling for this product: Undeclared D&C Red #33, FD&C Blue #1, Titanium Dioxide Suspension, Purified Water USP.
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
Docusate Calcium Softgel Capsules
Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets
Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets
Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets
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.
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.