Drug product
Glutamine/ORNI/Arginine/LYS/CITRU+LIDO 75 mg/75 mg/150 mg/50 mg/100 mg/10 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
D-0358-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 147 vials
- Official record key
drug-enforcement:D-0358-2017
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: 06232016@14, 07212016@2, 08012016@35, 08192016@11.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility