Why it was recalled
Lack of Assurance of Sterility
Product description
Norepinephrine 8 mg per 250 mL (32 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 70324-577-01.
Lot numbers, UPCs & expiration codes
Lot #: 490071, Exp 30-Jul-23; 490089, Exp 4-Aug-23; 490118, 490126, Exp 5-Aug-23; 490169, Exp 10-Aug-23; 491276, Exp 11-Aug-23; 491284, Exp 12-Aug-23; 491612, Exp 18-Aug-23; 497467, Exp 8-Dec-23; 497475, Exp 9-Dec-23; 499104, Exp 18-Jan-24; 499112, Exp 19-Jan-24; 499121, 499278, Exp 20-Jan-24; 499358, Exp 21-Jan-24; 502019, Exp 24-Mar-24; 502027, Exp 29-Mar-24; 502035, Exp 5-Apr-24; 503513, Exp 18-Apr-24; 504217, Exp 20-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-0932-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 7, 2023
- FDA report date
- Jul 26, 2023
- Quantity
- 125,598 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SterRx, LLC
Original FDA data
Every field from FDA enforcement report D-0932-2023, 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 #: 490071, Exp 30-Jul-23; 490089, Exp 4-Aug-23; 490118, 490126, Exp 5-Aug-23; 490169, Exp 10-Aug-23; 491276, Exp 11-Aug-23; 491284, Exp 12-Aug-23; 491612, Exp 18-Aug-23; 497467, Exp 8-Dec-23; 497475, Exp 9-Dec-23; 499104, Exp 18-Jan-24; 499112, Exp 19-Jan-24; 499121, 499278, Exp 20-Jan-24; 499358, Exp 21-Jan-24; 502019, Exp 24-Mar-24; 502027, Exp 29-Mar-24; 502035, Exp 5-Apr-24; 503513, Exp 18-Apr-24; 504217, Exp 20-Apr-24
- Postal code
- 12903-3987
- Report date
- Jul 26, 2023
- Product type
- Drugs
- Recall number
- D-0932-2023
- Classification
- Class II
- Recalling firm
- SterRx, LLC
- Product quantity
- 125,598 bags
- Termination date
- Jul 8, 2024
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Norepinephrine 8 mg per 250 mL (32 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 70324-577-01.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 7, 2023
- Initial firm notification
- Letter
- Center classification date
- Jul 19, 2023