Class II · Moderate risk
Man Power
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
FDA drug recalls in 2018
Every FDA drug recall initiated in 2018, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,681 recalls, newest first.
Class II · Moderate risk
Rejuvenation Plus
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
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.