Why it was recalled
Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at the round seal of the unused administrative port of the container.
Product description
HEPARIN SODIUM, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL flexible container unit, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7620-03
Lot numbers, UPCs & expiration codes
Lot #: 41-046-JT, Exp 11/01/2015
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-0324-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 11, 2014
- FDA report date
- Dec 31, 2014
- Quantity
- 63,378 flexible container units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-0324-2015, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 69214
- Address
- 275 N Field Dr
- Code information
- Lot #: 41-046-JT, Exp 11/01/2015
- Postal code
- 60045-2579
- Report date
- Dec 31, 2014
- Product type
- Drugs
- Recall number
- D-0324-2015
- Classification
- Class I
- Recalling firm
- Hospira Inc.
- Product quantity
- 63,378 flexible container units
- Termination date
- Jan 4, 2016
- Reason for recall
- Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at the round seal of the unused administrative port of the container.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HEPARIN SODIUM, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL flexible container unit, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7620-03
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 11, 2014
- Initial firm notification
- Letter
- Center classification date
- Dec 23, 2014