Drug product
Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile single use syringe, For IV use only, NDC: 42852-829-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
D-1024-2019
Product summary
- Event
- Event 82398
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5700 syringes
- Official record key
drug-enforcement:D-1024-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: 11/02/18 9350 82967S Exp. 4/1/2019; 10/23/18 1471 82967S Exp. 3/22/2019; 10/24/18 4412 82967S Exp. 3/23/2019; 10/24/18 0733 82967S Exp. 3/22/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility