Drug product
Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per carton, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-602-01.
D-0933-2023
Product summary
- Firm
- SterRx, LLC
- Event
- Event 92657
- Status
- Terminated
- Classification
- Class II
- Quantity
- 92,148 bags
- Official record key
drug-enforcement:D-0933-2023
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 490097, Exp 3-Aug-23; 490142, Exp 10-Aug-23; 491292, Exp 13-Aug-23; 494442, Exp 26-Nov-23; 496763, Exp 30-Nov-23; 496771, Exp 1-Dec-23; 497408, Exp 2-Dec-23; 497416, Exp 3-Dec-23; 499438, Exp 28-Jan-24; 501032, Exp 8-Feb-24; 501059, Exp 15-Feb-24; 502043, Exp 28-Mar-24; 502051, Exp 31-Mar-24; 503505, Exp 4-Apr-24; 504031, Exp 7-Apr-24; 504250, Exp 19-Apr-24
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility