Drug product
fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, QS, 100 mL, Sterile single use bag, NDC: 42852-210-10 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
D-1017-2019
Product summary
- Event
- Event 82398
- Status
- Terminated
- Classification
- Class II
- Quantity
- 360 bags
- Official record key
drug-enforcement:D-1017-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 01/03/19 1311 21010P Exp. 5/3/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility