Class II · Moderate risk Terminated
Brain Power
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Man Power
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Rejuvenation Plus
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Gentamicin Sulfate Ophthalmic Solution
Reason Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; bags have the potential to leak
Class II · Moderate risk Terminated
5% Dextrose Injection
Reason Lack of Assurance of Sterility; bags have the potential to leak
Class II · Moderate risk Terminated
Fluocinolone Acetonide Topical Solution
Reason Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
Class II · Moderate risk Terminated
Healthful Naturals Leg Cramp Support Oral Spray
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Healthful Naturals DizziFree Oral Spray
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Magnesium Sulfate in Water for Injection
Reason Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Heparin in 0.45% Sodium Chloride for Injection (NDC 0409-7651-03, Lot 87903FW) that was found inside a case of Magnesium Sulfate in Water for Injection.
Class II · Moderate risk Terminated
Pantoprazole Sodium Delayed-Release Tablets
Reason Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.
Class II · Moderate risk Terminated
Tesamorelin
Reason Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration date instead of a 6 month expiration date
Class II · Moderate risk Terminated
Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial
Reason Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Class II · Moderate risk Terminated
Prevacid 24HR
Reason CGMP deviations
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 II · Moderate risk Terminated
SparkleFresh Fluoride Toothpaste
Reason Microbial Contamination of Non-Sterile Product
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.