Class II · Moderate risk
Fentanyl Citrate
Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
FDA Drug Recalls
1,134 recalls, newest first
Class II · Moderate risk
Estrone
cGMP Deviations: lack of quality assurance at the API manufacturer.
Class II · Moderate risk
Estriol
cGMP Deviations: lack of quality assurance at the API manufacturer.
Class II · Moderate risk
Phenylephrine 2.5%
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
Testosterone Cypionate 200 mg/mL
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
Triamcinolone Diacetate 40 mg/mL
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
Triamcinolone Acetonide 40 mg/mL
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
Methylprednisolone Acetate 80 mg/mL
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
Methylprednisolone Acetate 40 mg/mL
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class III · Low risk
Doxercalciferol Capsules 0.5mcg
Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with illegible print.
Class II · Moderate risk
Refresh Tears
Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain the Drug Facts Panel.
Class II · Moderate risk
Estradiol
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class II · Moderate risk
Estradiol
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class II · Moderate risk
Estrone
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class II · Moderate risk
Estriol
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class II · Moderate risk
Alka-Seltzer Gold
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Class II · Moderate risk
Alka-Seltzer Extra Strength
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Class II · Moderate risk
Alka-Seltzer Original
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Class I · High risk
LaBri's Body Health Atomic
Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine.
Class III · Low risk
PrednisoLONE Oral Solution USP
Failed Stability Specifications
Class II · Moderate risk
hCG Body Shaper
Marketed without an Approved NDA/ANDA; FDA analysis has found the product to be tainted with human chorionic gonadotropin, rendering it an unapproved drug
Class II · Moderate risk
Nystatin and Triamcinolone Acetonide Cream
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
Class II · Moderate risk
Levonorgestrel Non-Micronized
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Ethinyl Estradiol Micronized
cGMP Deviations; lack of quality assurance.