Norepinephrine injectable recalled due to sterility assurance concerns
SterRx is recalling norepinephrine injections due to lack of assurance of sterility. The recall affects 132,299 bags distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an injectable medication due to lack of sterility assurance. Although no illnesses or injuries are reported in the source, the potential risk from non-sterile injectable medication warrants a High severity classification under the rubric for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
SterRx, LLC is recalling norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, supplied in 250 mL single-dose bags, packaged 12 units per case.
The recall is due to lack of assurance of sterility in the affected lots. Multiple lot numbers are affected, with expiration dates ranging from July 2023 through April 2024.
A total of 132,299 bags have been distributed nationwide in the United States. The product is prescription-only (Rx).
The recalled product
- Product
- Norepinephrine 4 mg per 250 mL (16 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 70324-552-01.
- Manufacturer
- SterRx, LLC
- Category
- Drug — Injectable
- Hazard
- lack-of-sterility
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot #: 490062
- Exp 22-Jul-23
- 490151
- Exp 28-Jul-23
- 490732
- Exp 6-Aug-23
- 491591
- Exp 17-Aug-23
- 491604
- Exp 18-Aug-23
- 494418
- Exp 16-Nov-23
- 494426
- Exp 17-Nov-23
- 494434
- Exp 23-Nov-23
- 496755
- Exp 25-Nov-23
- 497424
- Exp 3-Dec-23
Distribution
Distributed nationwide across the United States.
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