Class II · Moderate risk Terminated
5-Mthf 10ml Sdv
Reason Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
5-Mthf 10ml Mdv
Reason Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk Terminated
5-Mthf *10ml* Mdv 5mg/Ml Inj
Reason Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk Terminated
Riomet
Reason Microbial Contamination of Non-Sterile Products
Class II · Moderate risk Terminated
Estrone USP
Reason cGMP Deviations; lack of quality assurance.
Class III · Low risk Terminated
Zinc Oxide Paste 25%
Reason 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 Terminated
Allergy Relief Diphenhydramine HCl 25 mg
Reason Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.
Class II · Moderate risk Terminated
Eemt
Reason CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
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 I · High risk Terminated
Hyland's Baby Nighttime Teething Tablets
Reason 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 Terminated
Hyland's Baby Teething Tablets
Reason 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 Terminated
Desoximetasone Ointment USP
Reason Superpotent Drug
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.