Why it was recalled
Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
Product description
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10
Lot numbers, UPCs & expiration codes
Lot # 23AU05030, Exp 01/13/2024; 23AU05035, Exp 01/15/2024
Where it was sold
Product was distributed to 32 clinics in SC, NC and VA.
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-0777-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 23, 2023
- FDA report date
- Jun 7, 2023
- Quantity
- 53,424 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
Original FDA data
Every field from FDA enforcement report D-0777-2023, exactly as published.
Show all FDA fields
- City
- Waltham
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 92403
- Address
- 920 Winter St Bld 950
- Code information
- Lot # 23AU05030, Exp 01/13/2024; 23AU05035, Exp 01/15/2024
- Postal code
- 02451-1521
- Report date
- Jun 7, 2023
- Product type
- Drugs
- Recall number
- D-0777-2023
- Classification
- Class II
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Product quantity
- 53,424 bags
- Termination date
- May 23, 2024
- Reason for recall
- Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10
- Distribution pattern
- Product was distributed to 32 clinics in SC, NC and VA.
- Recall initiation date
- May 23, 2023
- Initial firm notification
- Letter
- Center classification date
- Jun 1, 2023