Drug product
Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration, 1x50ml 21 day expiration
D-491-2013
Product summary
- Event
- Event 65019
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
drug-enforcement:D-491-2013
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Code information: All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility