Why it was recalled
Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.
Product description
HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED AND DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045, NDC 0409-1555-54
Lot numbers, UPCs & expiration codes
Lot # 10-199-JT Exp. 10/13
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-184-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 22, 2012
- FDA report date
- Mar 13, 2013
- Quantity
- 11,412 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-184-2013, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 63522
- Address
- 275 N Field Dr
- Code information
- Lot # 10-199-JT Exp. 10/13
- Postal code
- 60045-2579
- Report date
- Mar 13, 2013
- Product type
- Drugs
- Recall number
- D-184-2013
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 11,412 bags
- Termination date
- Mar 31, 2015
- Reason for recall
- Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED AND DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045, NDC 0409-1555-54
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 22, 2012
- Initial firm notification
- Letter
- Center classification date
- Mar 5, 2013