Class I · High risk
PapaZen 3300 capsule
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
FDA Drug Recalls
18,003 recalls, newest first
Class I · High risk
RHINO 7 Platinum 5000
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Class I · High risk
Intralipid 20%
Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the acceptable storage range listed on the product labeling, during transit to a distribution facility.
Class II · Moderate risk
ChloraPrep OneStep
Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, the correct label should be Chloroprep with Tint (Hi Lite Orange)
Class II · Moderate risk
Aminocaproic Acid
CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.
Class II · Moderate risk
Procrit (epoetin alfa)
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Class III · Low risk
Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz.
Failed Stability Specifications
Class III · Low risk
Magnesium Citrate Oral Solution Cherry Flavor
Failed Impurities/Degradation Specifications.
Class III · Low risk
Magnesium Citrate Oral Solution Lemon Flavor
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
TYVASO (treprostinil)
CGMP Deviations
Class III · Low risk
AndroGel (testosterone gel)
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Class III · Low risk
AndroGel (testosterone gel)
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Class II · Moderate risk
Acarbose Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is printed on the product labeling rather than the correct expiration date of July 2017.
Class I · High risk
Activase (alteplase)
Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
Class III · Low risk
Phentermine
Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test
Class II · Moderate risk
Sterile Eyewash
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Class II · Moderate risk
Sterile Eyewash
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Class II · Moderate risk
Sterile Eyewash
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Class II · Moderate risk
Sterile Eyewash
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Class II · Moderate risk
Alcohol Prep Pads
Lack of Assurance of Sterility and cGMP Deviations
Class II · Moderate risk
Urin D/S Tablets Methenamine 81.6 mg
Superpotent Drug: Subpotent Drug. FDA analysis found this product to be Out of Specification for assay which could result in either Subpotent and/or Superpotent tablets.
Class III · Low risk
ENALAPRIL MALEATE Tablets
Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
Class II · Moderate risk
Sterile Water for Injection
Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.
Class II · Moderate risk
Class II · Moderate risk