Why it was recalled
Non-Sterility: fungal contamination due to leaking containers.
Product description
5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC 00264-1510-32
Lot numbers, UPCs & expiration codes
Lot #: J5J706, Exp. 10/31/2016
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-0094-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 25, 2016
- FDA report date
- Oct 19, 2016
- Quantity
- 57,408 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- B. Braun Medical Inc
Original FDA data
Every field from FDA enforcement report D-0094-2017, exactly as published.
Show all FDA fields
- City
- Irvine
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 73626
- Address
- 2525 McGaw Ave
- Code information
- Lot #: J5J706, Exp. 10/31/2016
- Postal code
- 92614-5841
- Report date
- Oct 19, 2016
- Product type
- Drugs
- Recall number
- D-0094-2017
- Classification
- Class I
- Recalling firm
- B. Braun Medical Inc
- Product quantity
- 57,408 units
- Termination date
- Oct 12, 2016
- Reason for recall
- Non-Sterility: fungal contamination due to leaking containers.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC 00264-1510-32
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 25, 2016
- Initial firm notification
- Letter
- Center classification date
- Oct 12, 2016