Class II · Moderate risk Terminated
Man Power
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
FDA Drug Recalls
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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 III · Low risk Terminated
Testosterone Topical Solution
Reason Defective Container: Repetitive complaints received indicating pump not working.
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 III · Low risk Terminated
Temozolomide capsules
Reason Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
Class III · Low risk Terminated
Contrave
Reason Container packaging defect.
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 I · High risk Terminated
Native Remedies EyeClear Pro Oral Spray
Reason Microbial Contamination of Non-Sterile Product
Class I · High risk Terminated
Native Remedies VaricoGo Oral Spray
Reason Microbial Contamination of Non-Sterile Products
Class I · High risk Terminated
Native Remedies HypoSlim Oral Spray
Reason Microbial Contamination of Non-Sterile Products
Class I · High risk Terminated
Native Remedies VertiFree Oral Spray
Reason Microbial Contamination of Non-Sterile Products
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 III · Low risk Terminated
Amlodipine Besylate USP 10 mg Tablets
Reason 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 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 III · Low risk Terminated
Levofloxacin Injection in 5% Dextrose
Reason Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Class III · Low risk Terminated
Tadalafil SR 12 mg Capsules packed in 8
Reason Labeling Not Elsewhere Classified: Misbranding.
Class III · Low risk Terminated
Tadalafil SR 7 mg Capsules packed in 8
Reason Labeling Not Elsewhere Classified: Misbranding.
Class III · Low risk Terminated
Progesterone SR 200 mg Capsules
Reason Labeling Not Elsewhere Classified: Misbranding.