Why it was recalled
Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust colored ring embedded in between the plastic layers of the plastic vial.
Product description
Sodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial, packaged in 25 vial Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4888-20.
Lot numbers, UPCs & expiration codes
Lot #: 15-058-DK*, Exp 1MAR2014; note the * may be followed by 01
Where it was sold
Nationwide and Guam
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-813-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 27, 2013
- FDA report date
- Jul 31, 2013
- Quantity
- 268,700 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-813-2013, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 65731
- Address
- 275 N Field Dr
- Code information
- Lot #: 15-058-DK*, Exp 1MAR2014; note the * may be followed by 01
- Postal code
- 60045-2579
- Report date
- Jul 31, 2013
- Product type
- Drugs
- Recall number
- D-813-2013
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 268,700 vials
- Termination date
- Jun 4, 2015
- Reason for recall
- Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust colored ring embedded in between the plastic layers of the plastic vial.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial, packaged in 25 vial Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4888-20.
- Distribution pattern
- Nationwide and Guam
- Recall initiation date
- Jun 27, 2013
- Initial firm notification
- Letter
- Center classification date
- Jul 22, 2013