Why it was recalled
Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution.
Product description
0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-25.
Lot numbers, UPCs & expiration codes
Lot # 45-110-C6; Exp 03/1/16
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-0976-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 5, 2015
- FDA report date
- May 13, 2015
- Quantity
- 9,912 VisIV flex containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-0976-2015, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 70818
- Address
- 275 N Field Dr
- Code information
- Lot # 45-110-C6; Exp 03/1/16
- Postal code
- 60045-2579
- Report date
- May 13, 2015
- Product type
- Drugs
- Recall number
- D-0976-2015
- Classification
- Class I
- Recalling firm
- Hospira Inc.
- Product quantity
- 9,912 VisIV flex containers
- Termination date
- Jun 9, 2016
- Reason for recall
- Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-25.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Mar 5, 2015
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- May 4, 2015