Class III · Low risk Terminated
Fluocinonide Gel USP
Reason Cross contamination with other products: traces of Dapsone were found in the finished product.
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Class II · Moderate risk Terminated
Symbio Muc Eye
Reason Lack of Assurance of Sterility
Class I · High risk Terminated
grande X 5800 capsule
Reason Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Class I · High risk Terminated
FIFTY SHADES 6000 capsule
Reason Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Class I · High risk Terminated
PapaZen 3300 capsule
Reason Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Class I · High risk Terminated
RHINO 7 Platinum 5000
Reason Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Class I · High risk Terminated
Intralipid 20%
Reason 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 Terminated
ChloraPrep OneStep
Reason 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 Terminated
Aminocaproic Acid
Reason CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.
Class II · Moderate risk Terminated
Procrit
Reason Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Class III · Low risk Terminated
Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz.
Reason Failed Stability Specifications
Class III · Low risk Terminated
Magnesium Citrate Oral Solution Cherry Flavor
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Terminated
Magnesium Citrate Oral Solution Lemon Flavor
Reason Failed Impurities/Degradation Specifications.
Class II · Moderate risk Terminated
Tyvaso
Reason CGMP Deviations
Class III · Low risk Terminated
AndroGel
Reason Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Class III · Low risk Terminated
AndroGel
Reason Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Class II · Moderate risk Terminated
Acarbose Tablets
Reason 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 Terminated
Activase
Reason Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
Class III · Low risk Terminated
Phentermine
Reason 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 Terminated
Sterile Eyewash
Reason Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Class II · Moderate risk Terminated
Sterile Eyewash
Reason Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Class II · Moderate risk Terminated
Sterile Eyewash
Reason Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Class II · Moderate risk Terminated
Sterile Eyewash
Reason Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Class II · Moderate risk Terminated
Alcohol Prep Pads
Reason Lack of Assurance of Sterility and cGMP Deviations
Class II · Moderate risk Terminated
Urin D/S Tablets Methenamine 81.6 mg
Reason 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.