Recalls / Class II
Class IID-0934-2023
Product
Norepinephrine 32 mg per 250 mL (128 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 70324-702-01.
- Affected lot / code info
- Lot #: 490100, Exp 27-Jul-23
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
- 2,088 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-0934-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.