Why it was recalled
Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter).
Product description
0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Braun Medical Inc, 2525 McGaw Ave, Irvine, CA 92614. NDC 0264-7802-00.
Lot numbers, UPCs & expiration codes
Lot No. J3D548, expiry: Oct, 2015
Where it was sold
Nationwide in the US and Puerto Rico.
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-407-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 27, 2013
- FDA report date
- Jan 22, 2014
- Quantity
- 19,572 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- B. Braun Medical Inc
Original FDA data
Every field from FDA enforcement report D-407-2014, exactly as published.
Show all FDA fields
- City
- Irvine
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 67095
- Address
- 2525 McGaw Ave
- Code information
- Lot No. J3D548, expiry: Oct, 2015
- Postal code
- 92614-5841
- Report date
- Jan 22, 2014
- Product type
- Drugs
- Recall number
- D-407-2014
- Classification
- Class II
- Recalling firm
- B. Braun Medical Inc
- Product quantity
- 19,572 bags
- Termination date
- Nov 1, 2014
- Reason for recall
- Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Braun Medical Inc, 2525 McGaw Ave, Irvine, CA 92614. NDC 0264-7802-00.
- Distribution pattern
- Nationwide in the US and Puerto Rico.
- Recall initiation date
- Nov 27, 2013
- Initial firm notification
- Letter
- Center classification date
- Jan 10, 2014