All Recalls

CGMP Deviations: Presence of NDMA impurity detected in product.

GMP Deviations: Product bottle may be absent of desiccant.

Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg.

CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.

Failed Dissolution Specifications: low out of specification results for dissolution testing.

GMP Deviations: Product bottle may be absent of desiccant.

Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions

The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

Incomplete seals on the sterile package may compromise the sterility

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of operator injury from an exposed aspiration needle.

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a result, you may experience either vision loss or non-recoverable errors 307 or 319, preventing further use of the system.

Incomplete seals on the sterile package may compromise the sterility

The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

Incomplete seals on the sterile package may compromise the sterility