Drug product
PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-701-01.
D-0305-2022
Product summary
- Firm
- SterRx, LLC
- Event
- Event 89059
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18,948 bags
- Official record key
drug-enforcement:D-0305-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: S21086/BQW 14-Dec-21 S21149/BTH 23-Jan-22 S21159/BTQ 30-Jan-22 S21265/BXI 3-Apr-22 S21305/BYU 24-Apr-22 S21311/BZA 26-Apr-22
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility