Class II · Moderate risk
5-Mthf *10ml* Mdv 5mg/Ml Inj
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
Riomet (metformin hydrochloride)
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Estrone USP
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
EEMT (esterified estrogens and methyltestosterone)
CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Class II · Moderate risk
EEMT HS (esterified estrogens and methyltestosterone)
CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Class II · Moderate risk
Levonorgestrel
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
Estradiol (17-B-Estradiol; Estra-1,3,5(10)
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
Fentanyl Citrate
Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
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.
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 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.