Why it was recalled
Lack of Assurance of Sterility
Product description
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.
Lot numbers, UPCs & expiration codes
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; 497432, Exp 4-Dec-23; 497441, 497459, Exp 7-Dec-23; 498005, Exp 10-Dec-23; 499075, Exp 22-Jan-24; 499083, 499091, Exp 25-Jan-24; 499391, Exp 26-Jan-24; 501964, Exp 23-Mar-24; 501972, Exp 28-Mar-24; 501981, Exp 30-Mar-24; 501999, Exp 6-Apr-24; 502001, Exp 7-Apr-24
Where it was sold
Nationwide in the USA
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-0931-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 7, 2023
- FDA report date
- Jul 26, 2023
- Quantity
- 132,299 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SterRx, LLC
Original FDA data
Every field from FDA enforcement report D-0931-2023, exactly as published.
Show all FDA fields
- City
- Plattsburgh
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 92657
- Address
- 141 Idaho Ave
- Code information
- 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; 497432, Exp 4-Dec-23; 497441, 497459, Exp 7-Dec-23; 498005, Exp 10-Dec-23; 499075, Exp 22-Jan-24; 499083, 499091, Exp 25-Jan-24; 499391, Exp 26-Jan-24; 501964, Exp 23-Mar-24; 501972, Exp 28-Mar-24; 501981, Exp 30-Mar-24; 501999, Exp 6-Apr-24; 502001, Exp 7-Apr-24
- Postal code
- 12903-3987
- Report date
- Jul 26, 2023
- Product type
- Drugs
- Recall number
- D-0931-2023
- Classification
- Class II
- Recalling firm
- SterRx, LLC
- Product quantity
- 132,299 bags
- Termination date
- Jul 8, 2024
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 7, 2023
- Initial firm notification
- Letter
- Center classification date
- Jul 19, 2023