Drug product
NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-651-01.
D-0320-2022
Product summary
- Firm
- SterRx, LLC
- Event
- Event 89059
- Status
- Terminated
- Classification
- Class II
- Quantity
- 121,584 bags
- Official record key
drug-enforcement:D-0320-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: S20415/BKY 12-Nov-21 S20418/BLB 13-Nov-21 S20452/BMI 5-Dec-21 S20463/BMT 9-Dec-21 S20464/BMU 18-Dec-21 S20478/BNF 23-Dec-21 S21021/BOI 6-Jan-22 S21033/BOU 20-Jan-22 S21047/BPH 21-Jan-22 S21059/BPU 28-Jan-22 S21094/BRE 18-Feb-22 S21117/BSB 3-Mar-22 S21118/BSC 10-Mar-22 S21138/BSW 17-Mar-22 S21227/BWA 7-May-22 S21239/BWK 12-May-22 S21279/BXW 5-Jun-22 S21295/BYL 16-Jun-22 S21298/BYO 18-Jun-22 S21339/BZZ 16-Jul-22 S21346/CAF 21-Jul-22 S21355/CAO 28-Jul-22 S21370/CBD 4-Aug-22 S21372/CBF 7-Aug-22 S21438/CDS 4-Sep-22
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility