Class II · Moderate risk
Carbon Dioxide
Impurities/Degradation Products: Out Of Specification levels of nitrogen dioxide.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Dr. Reddy's Ciprofloxacin Tablets
Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets
Class II · Moderate risk
Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg
Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets.
Class II · Moderate risk
Meloxicam Tablets
Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot.
Class II · Moderate risk
Mefloquine HCL Tablets
Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight.
Class II · Moderate risk
Daytrana (Methylphenidate)
Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value
Class II · Moderate risk
Metformin Hydrochloride Tablets
Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks. The same complainant also reported that metal shaving like material was observed on the surface of one tablet.
Class II · Moderate risk
Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX
Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle labeled Zolpidem Tartrate tables USP 10 mg
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 · 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