Why it was recalled
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Product description
Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7902-09.
Lot numbers, UPCs & expiration codes
Lot # 34-017-JT; Exp. 10/15 Lot # 35-100-JT; Exp. 11/15
Where it was sold
Nationwide, Puerto Rico, and U.S. Virgin Islands.
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-0278-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 14, 2014
- FDA report date
- Dec 3, 2014
- Quantity
- 836,460 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-0278-2015, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 69494
- Address
- 275 N Field Dr
- Code information
- Lot # 34-017-JT; Exp. 10/15 Lot # 35-100-JT; Exp. 11/15
- Postal code
- 60045-2579
- Report date
- Dec 3, 2014
- Product type
- Drugs
- Recall number
- D-0278-2015
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 836,460 bags
- Termination date
- Dec 28, 2015
- Reason for recall
- Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7902-09.
- Distribution pattern
- Nationwide, Puerto Rico, and U.S. Virgin Islands.
- Recall initiation date
- Oct 14, 2014
- Initial firm notification
- Letter
- Center classification date
- Nov 25, 2014