Class II · Moderate risk Terminated
Eemt
Reason CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Eemt Hs
Reason CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Class II · Moderate risk Terminated
Levonorgestrel
Reason CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.
Class II · Moderate risk Terminated
Estradiol
Reason CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.
Class II · Moderate risk Terminated
Fentanyl Citrate
Reason Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
Class II · Moderate risk Terminated
Fentanyl Citrate
Reason Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
Class II · Moderate risk Terminated
Estrone
Reason cGMP Deviations: lack of quality assurance at the API manufacturer.
Class II · Moderate risk Terminated
Estriol
Reason cGMP Deviations: lack of quality assurance at the API manufacturer.
Class II · Moderate risk Terminated
Phenylephrine 2.5%
Reason 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 Terminated
Testosterone Cypionate 200 mg/mL
Reason 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 Terminated
Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL
Reason 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 Terminated
Triamcinolone Diacetate 40 mg/mL
Reason 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 Terminated
Triamcinolone Acetonide 40 mg/mL
Reason 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 Terminated
Methylprednisolone Acetate 80 mg/mL
Reason 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 Terminated
Methylprednisolone Acetate 40 mg/mL
Reason 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 Terminated
Refresh Tears
Reason 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 Terminated
Estradiol
Reason cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class II · Moderate risk Terminated
Estradiol
Reason cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class II · Moderate risk Terminated
Estrone
Reason cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class II · Moderate risk Terminated
Estriol
Reason cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class II · Moderate risk Terminated
Alka-Seltzer Gold
Reason Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Class II · Moderate risk Terminated
Alka-Seltzer Extra Strength
Reason Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Class II · Moderate risk Terminated
Alka-Seltzer Original
Reason Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Class II · Moderate risk Terminated
hCG Body Shaper
Reason 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 Terminated
Nystatin and Triamcinolone Acetonide Cream
Reason Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability