Class II · Moderate risk Terminated
fentaNYL 2500 mcg/250 mL Injectable Solution
Reason Lack of Assurance of Sterility
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Class II · Moderate risk Terminated
fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
Testosterone Topical Solution
Reason Defective Container: Repetitive complaints received indicating pump not working.
Class II · Moderate risk Terminated
Dr. Berne's MSM DROPS 15% Solution
Reason Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Class II · Moderate risk Terminated
Red Eye
Reason Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Class II · Moderate risk Terminated
Dry Eye
Reason Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Class II · Moderate risk Terminated
15% Msm
Reason Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Class II · Moderate risk Terminated
Hydrocortisone and Acetic Acid Otic Solution
Reason Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
Class II · Moderate risk Terminated
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By…
Reason CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
Class II · Moderate risk Terminated
Volumex
Reason Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Class III · Low risk Terminated
Lansoprazole Delayed-Release Orally Disintegrating Tablets
Reason Subpotent Drug.
Class II · Moderate risk Terminated
Losartan Potassium USP
Reason CGMP deviation: Product found to contain trace amounts of NMBA
Class II · Moderate risk Terminated
Little Remedies New Baby Essentials Kit. Each kit contains 1 each…
Reason Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Class III · Low risk Terminated
Mirapex
Reason Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
Class II · Moderate risk Terminated
Losartan Potassium Tablets
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
Class II · Moderate risk Terminated
Valsartan Tablets USP 160 mg
Reason CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Class II · Moderate risk Terminated
Docetaxel Injection USP
Reason Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
Class I · High risk Terminated
LEOPARD Miracle Honey packaged in a wooden box
Reason Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approved drug for the treatment of male erectile dysfunction. The presence of sildenafil in Leopard Miracle Honey renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Class II · Moderate risk Terminated
Losartan Potassium and Hydrochlorothiazide Tablets
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Class II · Moderate risk Terminated
Losartan Potassium and Hydrochlorothiazide Tablets
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Class II · Moderate risk Terminated
Losartan Potassium Tablets USP 50 mg 50 Tablets
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Class II · Moderate risk Terminated
Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP
Reason CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
Class III · Low risk Terminated
ATHLETICARE Anti-Bacterial Hand Soap AC 550
Reason Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter consumer antiseptic/antibacterial wash products.
Class II · Moderate risk Terminated
Aspirin and Extended-release Dipyridamole Capsules
Reason Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.