Why it was recalled
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Product description
NORepinephrine added to 0.9% sodium chloride, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8097-1.
Lot numbers, UPCs & expiration codes
Lot # 37-884510, Exp 05/04/2023; 37-885671, Exp 05/09/2023; 37-886285, Exp 05/11/2023; 37-888322, Exp 05/21/2023; 37-888851, Exp 05/22/2023; 37-889840, Exp 05/25/2023; 37-890130, Exp 05/28/2023; 37-890966, Exp 05/30/2023; 37-893529, Exp 06/11/2023; 37-894766, Exp 06/14/2023; 37-895300, 37-895301, Exp 06/18/2023; 37-898521, Exp 06/29/2023; 37-900338, Exp 07/06/2023
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-0745-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 28, 2023
- FDA report date
- May 31, 2023
- Quantity
- 4994 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
Original FDA data
Every field from FDA enforcement report D-0745-2023, exactly as published.
Show all FDA fields
- City
- Allentown
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 92253
- Address
- 6580 Snowdrift Rd Ste 100
- Code information
- Lot # 37-884510, Exp 05/04/2023; 37-885671, Exp 05/09/2023; 37-886285, Exp 05/11/2023; 37-888322, Exp 05/21/2023; 37-888851, Exp 05/22/2023; 37-889840, Exp 05/25/2023; 37-890130, Exp 05/28/2023; 37-890966, Exp 05/30/2023; 37-893529, Exp 06/11/2023; 37-894766, Exp 06/14/2023; 37-895300, 37-895301, Exp 06/18/2023; 37-898521, Exp 06/29/2023; 37-900338, Exp 07/06/2023
- Postal code
- 18106-9331
- Report date
- May 31, 2023
- Product type
- Drugs
- Recall number
- D-0745-2023
- Classification
- Class II
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Product quantity
- 4994 bags
- Termination date
- Jun 22, 2025
- Reason for recall
- Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- NORepinephrine added to 0.9% sodium chloride, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8097-1.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Apr 28, 2023
- Initial firm notification
- Center classification date
- May 19, 2023