Drug product
GLUTATHIONE L REDUCED 100MG/ML (2ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 200MG/ML (1ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 220MG/ML (30ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (1ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (2ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED-PF- 200MG/ML (2ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
D-0210-2023
Product summary
- Event
- Event 91332
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0210-2023
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Code information: t20221129@68 t20221025@32 t20221025@33 t20221114@27 t20221021@40 t20221116@36
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility