Why it was recalled
Presence of Particulate; red and black particulate within the solution and embedded within the plastic vial identified as iron oxide
Product description
Potassium Chloride for Inj. Concentrate, USP, 40 mEq (2 mEq/mL), 20 mL Single-dose Fliptop Vial, For IV use, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA
Lot numbers, UPCs & expiration codes
Lot 22-127-DK
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-1261-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 27, 2014
- FDA report date
- Apr 30, 2014
- Quantity
- 255,900 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-1261-2014, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 67935
- Address
- 275 N Field Dr
- Code information
- Lot 22-127-DK
- Postal code
- 60045-2579
- Report date
- Apr 30, 2014
- Product type
- Drugs
- Recall number
- D-1261-2014
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 255,900 vials
- Termination date
- Jun 30, 2015
- Reason for recall
- Presence of Particulate; red and black particulate within the solution and embedded within the plastic vial identified as iron oxide
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Potassium Chloride for Inj. Concentrate, USP, 40 mEq (2 mEq/mL), 20 mL Single-dose Fliptop Vial, For IV use, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 27, 2014
- Initial firm notification
- Letter
- Center classification date
- Apr 24, 2014