Drug product
Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/10 mg/mL 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0444-2019
Product summary
- Event
- Event 81810
- Status
- Terminated
- Classification
- Class II
- Quantity
- 158 10 ml vials
- Official record key
drug-enforcement:D-0444-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 08302018@12 BUD: 12/24/2018; 10242018@2 BUD: 2/17/2019
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of sterility