Class II · Moderate risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications: Out of specification for impurities.
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Class II · Moderate risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class II · Moderate risk
Thyrogen (thyrotropin alfa for injection)
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Class II · Moderate risk
Thyrogen (thyrotropin alfa for injection)
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Class II · Moderate risk
Paliperidone Extended-release Tablets
Failed Dissolution Specifications; three month stability time point.
Class III · Low risk
Minocycline Hydrochloride Capsules USP
Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the correct lot number of 13650.
Class II · Moderate risk
Tobramycin 14 mg/mL Ophth Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Vancomycin 50mg/mL Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine Nebulizer 1% Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Edetate Disodium 2% Ophth Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Acetylcysteine 10% Ophth Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Atropine 0.01% Ophth Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Vancomycin 25mg/mL Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Tobramycin 15mg/mL Ophth Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Silver Nitrate 1% Ophth Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Rose Bengal 1% Ophth Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine Nebulizer 2% Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Edetate Disodium 3% Ophth Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Cefazolin 50 mg/mL Ophth Solution
Lack of Assurance of Sterility
Class III · Low risk
Scrub-Stat 4
Subpotent drug
Class I · High risk
Morphine Sulfate 0.5 mg/mL
Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.
Class II · Moderate risk
Alendronate Sodium Tablets
Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
Class III · Low risk
sulfur8 medicated LIGHT FORMULA
Subpotent Drug: failed at the 3 and 6 month stability time points.
Class III · Low risk
Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle
Labeling: Label Mix-Up
Class II · Moderate risk
TEARS Naturale FREE
Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the firm cannot guarantee the sterility of the water-filled vials.