Drug product
Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile single use syringe, For IV or IM use, NDC: 42852-828-22 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
D-1025-2019
Product summary
- Event
- Event 82398
- Status
- Terminated
- Classification
- Class II
- Quantity
- 140 syringes
- Official record key
drug-enforcement:D-1025-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: 10/31/18 2288 82822S Exp. 3/30/2019; 10/18/18 8371 82822S Exp. 3/17/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility