Drug product
PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-901-01.
D-0324-2022
Product summary
- Firm
- SterRx, LLC
- Event
- Event 89059
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23,136 bags
- Official record key
drug-enforcement:D-0324-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: S21088/BQY 19-Dec-21 S21152/BTK 25-Jan-22 S21161/BTS 31-Jan-22 S21289/BYG 4-Apr-22 S21309/BYY 25-Apr-22 S21314/BZD 2-May-22 S21378/CBL 12-Jun-22
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility