Drug product
Glutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
D-1159-2018
Product summary
- Event
- Event 80890
- Status
- Terminated
- Classification
- Class II
- Quantity
- 183 vials
- Official record key
drug-enforcement:D-1159-2018
Official wording
Reason: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Code information: Lot #: 180716/21, Exp 14-Oct-18
Distribution pattern: Nationwide in USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility