Recalls / Class I
Class ID-1257-2020
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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
- Affected lot / code info
- Lot #: H8J812, Exp. Date 31 JUL 2020
Why it was recalled
Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
Recalling firm
- Firm
- B. Braun Medical Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2525 Mcgaw Ave, N/A, Irvine, California 92614-5841
Distribution
- Quantity
- 22,488 Duplex containers
- Distribution pattern
- Product was distributed nationwide within the United States.
Timeline
- Recall initiated
- 2020-04-18
- FDA classified
- 2020-04-28
- Posted by FDA
- 2020-05-06
- Terminated
- 2021-10-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1257-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.