Why it was recalled
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Product description
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10
Lot numbers, UPCs & expiration codes
Lot # 22HU05062, 22HU06059, 22HU05035, EXP 06/30/2023; 22JU05001, EXP 07/31/2023
Where it was sold
Product was distributed 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-0075-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 22, 2022
- FDA report date
- Dec 14, 2022
- Quantity
- 4,097 cases/12 bags per case
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
Original FDA data
Every field from FDA enforcement report D-0075-2023, exactly as published.
Show all FDA fields
- City
- Waltham
- State
- MA
- Status
- Ongoing
- Country
- United States
- Event ID
- 91226
- Address
- 920 Winter St Bld 950
- Code information
- Lot # 22HU05062, 22HU06059, 22HU05035, EXP 06/30/2023; 22JU05001, EXP 07/31/2023
- Postal code
- 02451-1521
- Report date
- Dec 14, 2022
- Product type
- Drugs
- Recall number
- D-0075-2023
- Classification
- Class II
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Product quantity
- 4,097 cases/12 bags per case
- Reason for recall
- Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10
- Distribution pattern
- Product was distributed Nationwide in the USA.
- Recall initiation date
- Nov 22, 2022
- Initial firm notification
- Letter
- Center classification date
- Dec 2, 2022