Drug product
NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Injection, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-926-01.
D-0322-2022
Product summary
- Firm
- SterRx, LLC
- Event
- Event 89059
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36,576 bags
- Official record key
drug-enforcement:D-0322-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: S21082/BQV 13-Nov-21 S21102/BRM 28-Nov-21 S21135/BST 14-Dec-21 S21166/BTX 7-Jan-22 S21178/BUJ 28-Jan-22 S21226/BVZ 5-Feb-22 S21237/BWI 7-Feb-22 S21242/BWM 13-Feb-22 S21280/BXX 11-Mar-22 S21302/BYS 21-Mar-22 S21345/CAE 23-Apr-22 S21424/CDG 28-May-22
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility