Drug product
FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-327-01.
D-1331-2022
Product summary
- Firm
- SterRx, LLC
- Event
- Event 90653
- Status
- Terminated
- Classification
- Class II
- Quantity
- 720 bags
- Official record key
drug-enforcement:D-1331-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: CHI, Exp. Date Dec 22, 2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility