Drug product
Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-828-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
D-1021-2019
Product summary
- Event
- Event 82398
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2580 syringes
- Official record key
drug-enforcement:D-1021-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 12/05/18 0710 82867S Exp. 5/4/2019; 10/24/18 0014 82867S Exp. 3/23/2019; 11/01/18 8800 82867S Exp. 3/31/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility