Drug product
Glutamine/ORNI/ARGIN/LYSINE/LIDO Injectable, 75 mg/75 mg/150 mg/150 mg/10 mg/mL, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
D-0360-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 199 vials
- Official record key
drug-enforcement:D-0360-2017
Official wording
Reason: Lack of Assurance of Sterility
Code information: All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 06292016@9, 07252016@39, 08102016@24.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility