Prescription Drugs

CGMP Deviations: products manufactured under conditions that could impact its product quality.

Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.

Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.

CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.

CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.

Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.

CGMP deviations

Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metformin core of the Actoplus met XR tablets.

Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.

Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.

CGMP Deviations; rejected product was used to manufacture final bulk lot

CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.

CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.

Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Heparin in 0.45% Sodium Chloride for Injection (NDC 0409-7651-03, Lot 87903FW) that was found inside a case of Magnesium Sulfate in Water for Injection.

Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.

Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.

Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.

Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two to four tablets four times daily." rather than the correct dosage of "Two tablets three times daily."

Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.

Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.