Class II · Moderate risk
Rejuvenation Plus
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
FDA Drug Recalls
1,590 recalls, newest first
Class III · Low risk
Testosterone Topical Solution
Defective Container: Repetitive complaints received indicating pump not working.
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 III · Low risk
Temozolomide capsules
Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
Class III · Low risk
Contrave (naltrexone HCl and bupropion HCl)
Container packaging defect.
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 I · High risk
Native Remedies EyeClear Pro Oral Spray
Microbial Contamination of Non-Sterile Product
Class I · High risk
Native Remedies VaricoGo Oral Spray
Microbial Contamination of Non-Sterile Products
Class I · High risk
Native Remedies HypoSlim Oral Spray
Microbial Contamination of Non-Sterile Products
Class I · High risk
Native Remedies VertiFree Oral Spray
Microbial Contamination of Non-Sterile Products
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 III · Low risk
Amlodipine Besylate USP 10 mg Tablets
Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
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 III · Low risk
Levofloxacin Injection in 5% Dextrose
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Class III · Low risk
Tadalafil SR 12 mg Capsules packed in 8
Labeling Not Elsewhere Classified: Misbranding.
Class III · Low risk
Tadalafil SR 7 mg Capsules packed in 8
Labeling Not Elsewhere Classified: Misbranding.
Class III · Low risk
Progesterone SR 200 mg Capsules
Labeling Not Elsewhere Classified: Misbranding.
Class III · Low risk
Progesterone SR 100 mg Capsules
Labeling Not Elsewhere Classified: Misbranding.