Why it was recalled
CGMP Deviations
Product description
0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-09
Lot numbers, UPCs & expiration codes
Lot #: 91-016-JT, Exp. July 01, 2020
Where it was sold
Nationwide within 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-0509-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 4, 2019
- FDA report date
- Feb 27, 2019
- Quantity
- 475320 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ICU Medical Inc
Original FDA data
Every field from FDA enforcement report D-0509-2019, exactly as published.
Show all FDA fields
- City
- LAKE FOREST
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 82048
- Address
- 600 N FIELD DRIVE
- Code information
- Lot #: 91-016-JT, Exp. July 01, 2020
- Postal code
- 60045
- Report date
- Feb 27, 2019
- Product type
- Drugs
- Recall number
- D-0509-2019
- Classification
- Class II
- Recalling firm
- ICU Medical Inc
- Product quantity
- 475320 bags
- Termination date
- Jun 4, 2020
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-09
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Feb 4, 2019
- Initial firm notification
- Letter
- Center classification date
- Feb 19, 2019