Drug product
Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-02.
D-0317-2022
Product summary
- Firm
- SterRx, LLC
- Event
- Event 89059
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5000 bags
- Official record key
drug-enforcement:D-0317-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: S21353/CAM 26-Mar-22 S21358/CAR 30-Mar-22 S21364/CAX 6-Apr-22
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility