Class II · Moderate risk Terminated
Pge1 40 Mcg/Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 22-0.8 Mg-8 Mcg/Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Hydroxyprogesterone Caproate 250 Mg/Ml Oil* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Acetyl-L-Cysteine 10% P.F. Ophth Solution
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Dexamethasone
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
SODIUM CHLORIDE PRES-FREE 5% OPHTH STERILE* SOLUTION. 20ml eye drops
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Losartan Potassium and Hydrochlorothiazide Tablets
Reason CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Class II · Moderate risk Terminated
Topical Solution USP Hydrogen Peroxide First Aid Antiseptic Oral…
Reason Cross Contamination: Presence of IPA in finished product.
Class II · Moderate risk Terminated
Cefuroxime 10 mg/mL in Sodium Chloride
Reason Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
Class II · Moderate risk Terminated
Etomidate Injection
Reason Subpotent Drug.
Class II · Moderate risk Terminated
Dimercaptopropanesulfonate Sodium
Reason Presence of Particulate Matter: Particulates observed in vials release for dispensing.
Class II · Moderate risk Terminated
Life-Line tm Catalytic Activated Energy Water
Reason Unapproved new drug
Class II · Moderate risk Terminated
Indian Herb Paste
Reason Unapproved new drug
Class II · Moderate risk Terminated
MAGnesium 2 gm sulfate
Reason 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 Terminated
MAGnesium 2gm sulfate
Reason 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 Terminated
MAGnesium 1gm sulfate
Reason 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 Terminated
Labetalol 20mg
Reason 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 Terminated
Express Gel Hand Sanitizer
Reason Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class II · Moderate risk Terminated
Quick-Care Foam Hand Sanitizer
Reason Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class II · Moderate risk Terminated
Moisturizing Gel Hand Sanitizer
Reason Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class II · Moderate risk Terminated
Advanced Gel Hand Sanitizer
Reason Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class II · Moderate risk Terminated
Gel Hand Sanitizer
Reason Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class II · Moderate risk Terminated
Fentanyl in 0.9% Sodium Chloride QS 0.5 mL
Reason Labeling: Incorrect expiration date.
Class II · Moderate risk Terminated
Moisturizing Lubricant Eye Drops
Reason Failed Stability Specification: out of specification results for Sodium Perborate
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection
Reason CGMP Deviations