Why it was recalled
Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.
Product description
Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 USP Heparin Units/mL), 250 mL, Single-Dose Container, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7793-62
Lot numbers, UPCs & expiration codes
Lot # 34-811-KL, 36-106-KL, 36-114-KL; Exp. 12/15; 36-101-KL, Exp. 12/15; 37-202-KL, Exp. 1/16; 38-302-KL, Exp. 2/16; 38-305-KL, Exp. 2/16
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-1425-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 6, 2014
- FDA report date
- Jul 16, 2014
- Quantity
- 142,152 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-1425-2014, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 68631
- Address
- 275 N Field Dr
- Code information
- Lot # 34-811-KL, 36-106-KL, 36-114-KL; Exp. 12/15; 36-101-KL, Exp. 12/15; 37-202-KL, Exp. 1/16; 38-302-KL, Exp. 2/16; 38-305-KL, Exp. 2/16
- Postal code
- 60045-2579
- Report date
- Jul 16, 2014
- Product type
- Drugs
- Recall number
- D-1425-2014
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 142,152 bags
- Termination date
- Apr 3, 2015
- Reason for recall
- Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 USP Heparin Units/mL), 250 mL, Single-Dose Container, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7793-62
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 6, 2014
- Initial firm notification
- Letter
- Center classification date
- Jul 9, 2014