Why it was recalled
Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.
Product description
Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA, NDC 0338-0709-48, Product Code 2B0826.
Lot numbers, UPCs & expiration codes
Lot #: P319160, Exp 06/30/15
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-0256-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 10, 2014
- FDA report date
- Dec 3, 2014
- Quantity
- 63,360 container bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corp.
Original FDA data
Every field from FDA enforcement report D-0256-2015, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 69518
- Address
- 1 Baxter Pkwy
- Code information
- Lot #: P319160, Exp 06/30/15
- Postal code
- 60015-4625
- Report date
- Dec 3, 2014
- Product type
- Drugs
- Recall number
- D-0256-2015
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corp.
- Product quantity
- 63,360 container bags
- Termination date
- Nov 3, 2016
- Reason for recall
- Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA, NDC 0338-0709-48, Product Code 2B0826.
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 10, 2014
- Initial firm notification
- Letter
- Center classification date
- Nov 21, 2014