Why it was recalled
Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit.
Product description
Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System, 1 g in 50 mL duplex container, For IV Use Only, Single Dose, Sterile/Non pyrogenic, Rx Only, B Braun Medical Inc., NDC 0264-3193-11
Lot numbers, UPCs & expiration codes
Lot H3A744, Exp 01/15
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-1054-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Oct 15, 2013
- FDA report date
- Feb 12, 2014
- Quantity
- 18,936 Containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- B. Braun Medical Inc
Original FDA data
Every field from FDA enforcement report D-1054-2014, exactly as published.
Show all FDA fields
- City
- Irvine
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 66497
- Address
- 2525 McGaw Ave
- Code information
- Lot H3A744, Exp 01/15
- Postal code
- 92614-5841
- Report date
- Feb 12, 2014
- Product type
- Drugs
- Recall number
- D-1054-2014
- Classification
- Class I
- Recalling firm
- B. Braun Medical Inc
- Product quantity
- 18,936 Containers
- Termination date
- Dec 4, 2014
- Reason for recall
- Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System, 1 g in 50 mL duplex container, For IV Use Only, Single Dose, Sterile/Non pyrogenic, Rx Only, B Braun Medical Inc., NDC 0264-3193-11
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 15, 2013
- Initial firm notification
- Press Release
- Center classification date
- Jan 31, 2014