Prescription Drugs

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing.

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.