Drug product
PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-252-01.
D-0323-2022
Product summary
- Firm
- SterRx, LLC
- Event
- Event 89059
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20640 bags
- Official record key
drug-enforcement:D-0323-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: S21087/BQX 16-Dec-21 S21151/BTJ 24-Jan-22 S21186/BUQ 14-Feb-22 S21189/BUS 16-Feb-22 S21266/BXJ 3-Apr-22 S21307/BYW 24-Apr-22 S21313/BZC 27-Apr-22
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility