Fentanyl Transdermal System
Subpotent; some patches may not contain fentanyl gel
401 recalls · Class II, newest first
Subpotent; some patches may not contain fentanyl gel
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.
Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample.
Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are beig recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation
Subpotent (Single Ingredient) Drug: This product is being recalled because of sub-potency of the sennosides.
Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)
Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)