Drug product
Amino Blend Glutamine 30 mg/mL Ornithine HCL 50 mg/mL Arginine HCL 100 mg/mL Lysine HCL 50 mg/mL Citrulline 50 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835.NDC 73198-0129-30.
D-0949-2022
Product summary
- Event
- Event 90204
- Status
- Completed
- Classification
- Class II
- Quantity
- 7761 vials
- Official record key
drug-enforcement:D-0949-2022
Official wording
Reason: Lack of assurance of sterility.
Code information: Lots: A24104, A24304 BUD: 7/4/2022; A24303 BUD: 7/3/2022; B2422322, B24123-22 BUD: 8/22/2022
Distribution pattern: Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility