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
Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7953-09.
Lot numbers, UPCs & expiration codes
Lot # 32-099-JT; Exp. 08/15 Lot # 32-103-JT; Exp. 08/15 Lot # 34-070-JT; Exp. 10/15 Lot # 34-086-JT; Exp. 10/15 Lot # 34-165-JT; Exp. 10/15 Lot # 35-085-JT; Exp. 11/15 Lot # 35-115-JT; Exp. 11/15 Lot # 35-121-JT; Exp. 11/15 Lot # 36-057-JT; Exp. 12/15
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-0283-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 14, 2014
- FDA report date
- Dec 3, 2014
- Quantity
- 6,193,416 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-0283-2015, 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 # 32-099-JT; Exp. 08/15 Lot # 32-103-JT; Exp. 08/15 Lot # 34-070-JT; Exp. 10/15 Lot # 34-086-JT; Exp. 10/15 Lot # 34-165-JT; Exp. 10/15 Lot # 35-085-JT; Exp. 11/15 Lot # 35-115-JT; Exp. 11/15 Lot # 35-121-JT; Exp. 11/15 Lot # 36-057-JT; Exp. 12/15
- Postal code
- 60045-2579
- Report date
- Dec 3, 2014
- Product type
- Drugs
- Recall number
- D-0283-2015
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 6,193,416 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
- Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7953-09.
- 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