Class II · Moderate risk
TravelEase
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
SleepEase
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
DigestivEase
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Cold + Flu Relief
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
AllergEase
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Bone Builder
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
MenoPower
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Woman Power
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Brain Power
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Man Power
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Rejuvenation Plus
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Gentamicin Sulfate Ophthalmic Solution
Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; bags have the potential to leak
Class II · Moderate risk
5% Dextrose Injection
Lack of Assurance of Sterility; bags have the potential to leak
Class II · Moderate risk
Fluocinolone Acetonide Topical Solution
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
Class II · Moderate risk
Healthful Naturals Leg Cramp Support Oral Spray
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Healthful Naturals DizziFree Oral Spray
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Magnesium Sulfate in Water for Injection
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
Pantoprazole Sodium Delayed-Release Tablets
Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.
Class II · Moderate risk
Tesamorelin
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
Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Class II · Moderate risk
Prevacid 24HR
CGMP deviations
Class II · Moderate risk
Lidocaine 1% + Epinephrine 1:100
Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent.
Class II · Moderate risk
Nystatin and Triamcinolone Acetonide Cream
Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
Class II · Moderate risk
Clozapine Orally Disintegrating Tablets
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.