Drug product
Glutathione 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy
D-0260-2017
Product summary
- Event
- Event 75763
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 367 vials
- Official record key
drug-enforcement:D-0260-2017
Official wording
Reason: Lack of Assurance of Sterility
Code information: Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06082016A (09/06/2016), 07052016C (10/03/2016), 08082016A (11/06/2016), 09132016D (12/12/2016), 10262016A (01/24/2016).
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility