Why it was recalled
Defective container
Product description
Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-475-15
Lot numbers, UPCs & expiration codes
Lot #: F2101639, F2101642, F2101644, F2101645, Exp 4/30/22; F2101674, F2101675, F2101676, Exp 5/05/22; F2101790, F2101791, F2101792, F2101793, F2101794, Exp 5/26/22; F2101813, Exp 5/29/22
Where it was sold
USA nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0708-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 14, 2022
- FDA report date
- Mar 30, 2022
- Quantity
- 9,800 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Athenex Pharma Solutions, LLC
Original FDA data
Every field from FDA enforcement report D-0708-2022, exactly as published.
Show all FDA fields
- City
- Clarence
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 89779
- Address
- 11342 Main St
- Code information
- Lot #: F2101639, F2101642, F2101644, F2101645, Exp 4/30/22; F2101674, F2101675, F2101676, Exp 5/05/22; F2101790, F2101791, F2101792, F2101793, F2101794, Exp 5/26/22; F2101813, Exp 5/29/22
- Postal code
- 14031-1718
- Report date
- Mar 30, 2022
- Product type
- Drugs
- Recall number
- D-0708-2022
- Classification
- Class II
- Recalling firm
- Athenex Pharma Solutions, LLC
- Product quantity
- 9,800 bags
- Termination date
- Aug 4, 2022
- Reason for recall
- Defective container
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-475-15
- Distribution pattern
- USA nationwide.
- Recall initiation date
- Mar 14, 2022
- Initial firm notification
- Letter
- Center classification date
- Mar 21, 2022