Drug product
EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-052-01.
D-0309-2022
Product summary
- Firm
- SterRx, LLC
- Event
- Event 89059
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7548 bags
- Official record key
drug-enforcement:D-0309-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: S21255/BXA 22-Jan-22 S21264/BXH 29-Jan-22 S21328/BZO 10-Mar-22
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility