Recalls / Class II
Class IID-0932-2023
Product
Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-577-01.
- Affected lot / code info
- Lot #: 490071, Exp 30-Jul-23; 490089, Exp 4-Aug-23; 490118, 490126, Exp 5-Aug-23; 490169, Exp 10-Aug-23; 491276, Exp 11-Aug-23; 491284, Exp 12-Aug-23; 491612, Exp 18-Aug-23; 497467, Exp 8-Dec-23; 497475, Exp 9-Dec-23; 499104, Exp 18-Jan-24; 499112, Exp 19-Jan-24; 499121, 499278, Exp 20-Jan-24; 499358, Exp 21-Jan-24; 502019, Exp 24-Mar-24; 502027, Exp 29-Mar-24; 502035, Exp 5-Apr-24; 503513, Exp 18-Apr-24; 504217, Exp 20-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
- 125,598 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-0932-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.