Why it was recalled
Lack of Assurance of Sterility
Product description
0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
Lot numbers, UPCs & expiration codes
Lot # 17LU05005; Exp. 09/18 Part Number 060-10109
Where it was sold
Product was distributed throughout the United States.
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-0827-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 13, 2017
- FDA report date
- May 30, 2018
- Quantity
- 25,356 1 liter bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
Original FDA data
Every field from FDA enforcement report D-0827-2018, exactly as published.
Show all FDA fields
- City
- Waltham
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 79501
- Address
- 920 Winter St
- Code information
- Lot # 17LU05005; Exp. 09/18 Part Number 060-10109
- Postal code
- 02451-1521
- Report date
- May 30, 2018
- Product type
- Drugs
- Recall number
- D-0827-2018
- Classification
- Class II
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Product quantity
- 25,356 1 liter bags
- Termination date
- Dec 6, 2018
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
- Distribution pattern
- Product was distributed throughout the United States.
- Recall initiation date
- Nov 13, 2017
- Initial firm notification
- Letter
- Center classification date
- May 22, 2018