Drug and pharmaceutical recalls

Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.

Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.

Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.

Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.

Presence of Particulate Matter.

Presence of Particulate Matter.

Presence of Particulate Matter.

Presence of Particulate Matter: One vial was found to contain a hair.

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.

Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.

Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.

Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.

Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)

Failed Impurities/Degradation Specifications; 18 month long term stability study.

Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient

Unapproved new drug

Unapproved new drug

Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.

Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.

Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.

Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.

Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.

Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.