Class II · Moderate risk
Papaverine-Phentolamine-Pge1 12-1mg-10mcg/Ml Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 30-1 Mg-10 Mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine 30-1 Mg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Pge1 40 Mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 22-0.8 Mg-8 Mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Hydroxyprogesterone Caproate 250 Mg/Ml Oil* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Acetyl-L-Cysteine 10% P.F. Ophth Solution
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Dexamethasone
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
SODIUM CHLORIDE PRES-FREE 5% OPHTH STERILE* SOLUTION. 20ml eye drops
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Class II · Moderate risk
Topical Solution USP Hydrogen Peroxide First Aid Antiseptic Oral…
Cross Contamination: Presence of IPA in finished product.
Class II · Moderate risk
Cefuroxime 10 mg/mL in Sodium Chloride
Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
Class II · Moderate risk
Etomidate Injection
Subpotent Drug.
Class II · Moderate risk
Dimercaptopropanesulfonate Sodium
Presence of Particulate Matter: Particulates observed in vials release for dispensing.
Class II · Moderate risk
Life-Line tm Catalytic Activated Energy Water
Unapproved new drug
Class II · Moderate risk
Indian Herb Paste
Unapproved new drug
Class II · Moderate risk
MAGnesium 2 gm sulfate
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
Class II · Moderate risk
MAGnesium 2gm sulfate
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
Class II · Moderate risk
MAGnesium 1gm sulfate
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
Class II · Moderate risk
Labetalol 20mg
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
Class II · Moderate risk
Express Gel Hand Sanitizer
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class II · Moderate risk
Quick-Care Foam Hand Sanitizer
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class II · Moderate risk
Moisturizing Gel Hand Sanitizer
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class II · Moderate risk
Advanced Gel Hand Sanitizer
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class II · Moderate risk
Gel Hand Sanitizer
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.