Drugs Recalls

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Subpotent Drug; out of specification results for heparin raw material

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Labeling: incorrect or missing lot number and/or expiration date

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Failed Impurities/Degradation Specifications

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Failed Impurities/Degradation Specifications

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Honey Lemon lozenges was applied to the underside of the Sucrets Sore Throat & Cough Vapor Cherry lozenges tin.

Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.

Failed Dissolution Specifications: OOS result during stability testing

Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids

Failed Dissolution Specifications: Low out of specification dissolution results.