Why it was recalled
Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container.
Product description
0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08
Lot numbers, UPCs & expiration codes
Lot 13-121-JT* * the lot number may be followed by 01
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-176-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 12, 2013
- FDA report date
- Mar 6, 2013
- Quantity
- 56,854 Units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-176-2013, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 64441
- Address
- 275 N Field Dr
- Code information
- Lot 13-121-JT* * the lot number may be followed by 01
- Postal code
- 60045-2579
- Report date
- Mar 6, 2013
- Product type
- Drugs
- Recall number
- D-176-2013
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 56,854 Units
- Termination date
- Apr 24, 2015
- Reason for recall
- Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 12, 2013
- Initial firm notification
- Letter
- Center classification date
- Feb 28, 2013