Class III · Low risk Terminated
Progesterone SR 100 mg Capsules
Reason Labeling Not Elsewhere Classified: Misbranding.
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Lidocaine 1% + Epinephrine 1:100
Reason Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent.
Class II · Moderate risk Terminated
Nystatin and Triamcinolone Acetonide Cream
Reason Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
Class II · Moderate risk Terminated
Clozapine Orally Disintegrating Tablets
Reason Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Class II · Moderate risk Terminated
Meropenem for Injection
Reason Lack of assurance of sterility: loss of container integrity.
Class II · Moderate risk Terminated
Clonazepam Orally Disintegrating Tablets USP
Reason Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.
Class II · Moderate risk Terminated
Glipizide XL
Reason CGMP Deviations; rejected product was used to manufacture final bulk lot
Class II · Moderate risk Terminated
Bumetanide Tablets
Reason Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Class II · Moderate risk Terminated
Bumetanide Tablets
Reason Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Class II · Moderate risk Terminated
Elelyso
Reason Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
Class III · Low risk Terminated
Altavera Levonorgestrel and Ethinyl Estradiol Tablets
Reason Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
Class II · Moderate risk Terminated
SparkleFresh Fluoride Toothpaste
Reason Microbial Contamination of Non-Sterile Product
Class III · Low risk Terminated
treatNOW ABILIFY
Reason Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.
Class III · Low risk Terminated
treatNOW ABILIFY
Reason Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.
Class I · High risk Terminated
robaxin-750
Reason Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two to four tablets four times daily." rather than the correct dosage of "Two tablets three times daily."
Class III · Low risk Terminated
Fenofibrate Tablets
Reason Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.
Class III · Low risk Terminated
Zoledronic Acid Injection
Reason Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Class III · Low risk Terminated
Zoledronic Acid Injection
Reason Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Class II · Moderate risk Terminated
Lamotrigine Extended-Release Tablets
Reason Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Class II · Moderate risk Terminated
Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Testosterone in Grapeseed Oil 200 mg/mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Zinc Sulfate 1 mg/mL MDV Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Water Sterile for Injection 250 mL IV Pharm D Solutions
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Vigamox Oph. Solution Pharm D Solutions
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix T105 PGE/Phentolamine/Papaverine 10 mcg/30 mg/1 mg…
Reason Lack of Assurance of Sterility