Why it was recalled
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Product description
20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC 0409-7935-19), b) 500 mL VisIV Container (NDC 0409-7953-30), c) 1000 mL VisIV Container, (NDC 0409-7953-48), Rx Only, Hospira, Inc., Lake Forest, IL 60045
Lot numbers, UPCs & expiration codes
Lot #: a) 09-183-JT, Exp 3/13; b) 01-081-JT, Exp 7/12; c) 07-078-JT, 91-083-JT, Exp 7/12
Where it was sold
Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia
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-616-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 4, 2012
- FDA report date
- Jul 3, 2013
- Quantity
- 216,396 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-616-2013, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 61918
- Address
- 275 N Field Dr
- Code information
- Lot #: a) 09-183-JT, Exp 3/13; b) 01-081-JT, Exp 7/12; c) 07-078-JT, 91-083-JT, Exp 7/12
- Postal code
- 60045-2579
- Report date
- Jul 3, 2013
- Product type
- Drugs
- Recall number
- D-616-2013
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 216,396 units
- Termination date
- Jul 17, 2015
- Reason for recall
- Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC 0409-7935-19), b) 500 mL VisIV Container (NDC 0409-7953-30), c) 1000 mL VisIV Container, (NDC 0409-7953-48), Rx Only, Hospira, Inc., Lake Forest, IL 60045
- Distribution pattern
- Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia
- Recall initiation date
- May 4, 2012
- Initial firm notification
- Letter
- Center classification date
- Jun 21, 2013