Why it was recalled
Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
Product description
Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11
Lot numbers, UPCs & expiration codes
Lot #: H8J812, Exp. Date 31 JUL 2020
Where it was sold
Product was distributed nationwide within the United States.
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-1257-2020
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Apr 18, 2020
- FDA report date
- May 6, 2020
- Quantity
- 22,488 Duplex containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- B. Braun Medical Inc
Original FDA data
Every field from FDA enforcement report D-1257-2020, exactly as published.
Show all FDA fields
- City
- Irvine
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 85507
- Address
- 2525 Mcgaw Ave
- Code information
- Lot #: H8J812, Exp. Date 31 JUL 2020
- Postal code
- 92614-5841
- Report date
- May 6, 2020
- Product type
- Drugs
- Recall number
- D-1257-2020
- Classification
- Class I
- Recalling firm
- B. Braun Medical Inc
- Product quantity
- 22,488 Duplex containers
- Termination date
- Oct 21, 2021
- Reason for recall
- Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11
- Distribution pattern
- Product was distributed nationwide within the United States.
- Recall initiation date
- Apr 18, 2020
- Initial firm notification
- Letter
- Center classification date
- Apr 28, 2020