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.
FDA Drug Recalls
18,003 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 III · Low risk
Zinc Oxide Paste 25%
Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.
Class III · Low risk
Allergy Relief Diphenhydramine HCl 25 mg
Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.
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 I · High risk
Hyland's Baby Nighttime Teething Tablets
Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
Class I · High risk
Hyland's Baby Teething Tablets
Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
Class III · Low risk
Desoximetasone Ointment USP
Superpotent Drug
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 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.