Drug product
EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-227-01.
D-0308-2022
Product summary
- Firm
- SterRx, LLC
- Event
- Event 89059
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26,928 bags
- Official record key
drug-enforcement:D-0308-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: S21254/BWZ 22-Nov-21 S21263/BXG 30-Nov-21 S21333/BZT 11-Jan-22 S21398/CCG 19-Feb-22
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility