Drugs Recalls

Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

Superpotent Drug: above specification for the assay.

GMP Deviations; product may not meet cGMP requirements

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

Defective Delivery System: Elevated number of units with out of specification results for leak rate

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine.

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.