Norepinephrine Bitartrate Injection Recalled Due to Defective Container
Athenex Pharma Solutions is recalling Norepinephrine Bitartrate Injection due to defective containers affecting specific lots 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: FDA Class II recall of an injectable pharmaceutical with a defective container poses a risk of contamination and compromised product integrity. No illnesses or injuries have been reported, fitting the criteria for a High severity classification for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Athenex Pharma Solutions, LLC is recalling Norepinephrine Bitartrate Injection 4 mg per 250 mL in 0.9% Sodium Chloride due to defective containers. The defective container issue affects specific production lots and was identified by the manufacturer.
The recall affects 4,270 bags distributed nationwide across the United States. The recalled lots are: F2101628, F2101629, F2101630, F2101631 (expiration 4/28/22), F2101632, F2101633 (expiration 4/29/22), F2101795, and F2101796 (expiration 5/27/22).
Healthcare providers and patients with this medication should verify the lot number against the recalled list. Those with affected lots should consult with their healthcare provider or pharmacist regarding appropriate action. This is an FDA Class II recall that was initiated voluntarily by the manufacturer on March 14, 2022.
The recalled product
- Product
- Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride, 4 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-474-15
- Manufacturer
- Athenex Pharma Solutions, LLC
- Category
- Drug — Injectable Medication
- Hazard
- defective-container
- contamination-risk
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 (11)
- Lot #: F2101628
- F2101629
- F2101630
- F2101631
- Exp 4/28/22
- F2101632
- F2101633
- Exp 4/29/22
- F2101795
- F2101796
- Exp 5/27/22
Distribution
Distributed nationwide across the United States.
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