Recalls / Class II
Class IID-0210-2023
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.
- Affected lot / code info
- t20221129@68 t20221025@32 t20221025@33 t20221114@27 t20221021@40 t20221116@36
Why it was recalled
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Recalling firm
- Firm
- Pharmacy Innovations
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 2936 W 17th St, N/A, Erie, Pennsylvania 16505-3929
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-12-22
- FDA classified
- 2023-01-26
- Posted by FDA
- 2023-02-01
- Terminated
- 2024-07-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0210-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.