Why it was recalled
CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
Product description
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451
Lot numbers, UPCs & expiration codes
Lot #: 19EG02012, 19EG02019, Exp. Date 05/2020; 19DG02050, Exp. Date 04/2020
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-1064-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 5, 2020
- FDA report date
- Mar 25, 2020
- Quantity
- 32,592 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
Original FDA data
Every field from FDA enforcement report D-1064-2020, exactly as published.
Show all FDA fields
- City
- Waltham
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 85228
- Address
- 920 Winter St Bld 950
- Code information
- Lot #: 19EG02012, 19EG02019, Exp. Date 05/2020; 19DG02050, Exp. Date 04/2020
- Postal code
- 02451-1521
- Report date
- Mar 25, 2020
- Product type
- Drugs
- Recall number
- D-1064-2020
- Classification
- Class II
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Product quantity
- 32,592 bags
- Termination date
- Feb 3, 2023
- Reason for recall
- CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451
- Distribution pattern
- Product was distributed throughout the United States.
- Recall initiation date
- Mar 5, 2020
- Initial firm notification
- Letter
- Center classification date
- Mar 26, 2020