Why it was recalled
Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.
Product description
Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile single dose container bags, Rx only, Baxter USA, product code 2B0826, NDC 0338-0709-48.
Lot numbers, UPCs & expiration codes
Lot P318220, EXP 05/31/15
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-1606-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 8, 2014
- FDA report date
- Oct 1, 2014
- Quantity
- 148632 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corp
Original FDA data
Every field from FDA enforcement report D-1606-2014, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 69130
- Address
- 1 Baxter Pkwy
- Code information
- Lot P318220, EXP 05/31/15
- Postal code
- 60015-4625
- Report date
- Oct 1, 2014
- Product type
- Drugs
- Recall number
- D-1606-2014
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corp
- Product quantity
- 148632 bags
- Termination date
- Sep 27, 2016
- Reason for recall
- Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile single dose container bags, Rx only, Baxter USA, product code 2B0826, NDC 0338-0709-48.
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 8, 2014
- Initial firm notification
- Letter
- Center classification date
- Sep 23, 2014