Why it was recalled
Lack of Assurance of Sterility; bags have the potential to leak
Product description
0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-7984-36; d) 100 mL NDC 0409-7984-37, Hospira, Inc. Lake Forest, IL 60045
Lot numbers, UPCs & expiration codes
Lots: a) 84-011-JT Exp. December 01, 2019 and 85-014-JT Exp. January 01, 2020; b) 84-015-JT Exp. December 01, 2019; c) 84-016-JT Exp. June 01, 2019; d) 84-005-JT Exp. December 01, 2019 and 84-014-JT Exp. December 01, 2019
Where it was sold
Nationwide.
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-0216-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 8, 2018
- FDA report date
- Nov 14, 2018
- Quantity
- 2,580,448 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ICU Medical Inc
Original FDA data
Every field from FDA enforcement report D-0216-2019, exactly as published.
Show all FDA fields
- City
- LAKE FOREST
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 81199
- Address
- 600 N FIELD DRIVE
- Code information
- Lots: a) 84-011-JT Exp. December 01, 2019 and 85-014-JT Exp. January 01, 2020; b) 84-015-JT Exp. December 01, 2019; c) 84-016-JT Exp. June 01, 2019; d) 84-005-JT Exp. December 01, 2019 and 84-014-JT Exp. December 01, 2019
- Postal code
- 60045
- Report date
- Nov 14, 2018
- Product type
- Drugs
- Recall number
- D-0216-2019
- Classification
- Class II
- Recalling firm
- ICU Medical Inc
- Product quantity
- 2,580,448 bags
- Termination date
- Mar 8, 2021
- Reason for recall
- Lack of Assurance of Sterility; bags have the potential to leak
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-7984-36; d) 100 mL NDC 0409-7984-37, Hospira, Inc. Lake Forest, IL 60045
- Distribution pattern
- Nationwide.
- Recall initiation date
- Oct 8, 2018
- Initial firm notification
- Letter
- Center classification date
- Nov 2, 2018