Why it was recalled
Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrectly released without meeting product specifications. There is the potential for the solution to leak from the administrative port to the fill tube seal.
Product description
0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7984-36 Hospira, Inc., Lake Forest, IL 60045
Lot numbers, UPCs & expiration codes
Lot #: 22-028-JT Exp 04/14
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-243-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 18, 2013
- FDA report date
- Apr 10, 2013
- Quantity
- 624,240 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-243-2013, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 64481
- Address
- 275 N Field Dr
- Code information
- Lot #: 22-028-JT Exp 04/14
- Postal code
- 60045-2579
- Report date
- Apr 10, 2013
- Product type
- Drugs
- Recall number
- D-243-2013
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 624,240 units
- Termination date
- Apr 6, 2015
- Reason for recall
- Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrectly released without meeting product specifications. There is the potential for the solution to leak from the administrative port to the fill tube seal.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7984-36 Hospira, Inc., Lake Forest, IL 60045
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 18, 2013
- Initial firm notification
- Letter
- Center classification date
- Apr 4, 2013