Drugs Recalls

Microbial Contamination of Non-Sterile Products: Weight Away Remedy is being recall due to out of specification microbial results.

Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.

Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

Lack of assurance of sterility.

CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.

Lack of assurance of sterility.

Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Lack of assurance of sterility.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Subpotency: lower than expected potency result was obtained at the 18 month stability time point.

Lack of assurance of sterility.