Drug product
Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile single use syringe, NDC: 42852-827-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
D-1029-2019
Product summary
- Event
- Event 82398
- Status
- Terminated
- Classification
- Class II
- Quantity
- 550 syringes
- Official record key
drug-enforcement:D-1029-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 11/06/18 5007 82761S Exp. 4/5/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility