Drug product
fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-327-02.
D-1332-2022
Product summary
- Firm
- SterRx, LLC
- Event
- Event 90653
- Status
- Terminated
- Classification
- Class II
- Quantity
- 360 bags
- Official record key
drug-enforcement:D-1332-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: CHL, Exp. Date Dec 29, 2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility