Why it was recalled
Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold
Product description
LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7828-08.
Lot numbers, UPCs & expiration codes
Lot # 40-008-JT; Exp. 04/01/16
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-1108-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 11, 2015
- FDA report date
- Jun 3, 2015
- Quantity
- 24,744 flexible container bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-1108-2015, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 70700
- Address
- 275 N Field Dr
- Code information
- Lot # 40-008-JT; Exp. 04/01/16
- Postal code
- 60045-2579
- Report date
- Jun 3, 2015
- Product type
- Drugs
- Recall number
- D-1108-2015
- Classification
- Class I
- Recalling firm
- Hospira Inc.
- Product quantity
- 24,744 flexible container bags
- Termination date
- Jan 2, 2017
- Reason for recall
- Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7828-08.
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 11, 2015
- Initial firm notification
- Letter
- Center classification date
- May 28, 2015