Recalls / Class II
Class IID-0933-2023
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.
- Affected lot / code info
- 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
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- SterRx, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 141 Idaho Ave, N/A, Plattsburgh, New York 12903-3987
Distribution
- Quantity
- 92,148 bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-07-07
- FDA classified
- 2023-07-19
- Posted by FDA
- 2023-07-26
- Terminated
- 2024-07-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0933-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.