Recalls / Class I
Class ID-0094-2017
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
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
- Affected lot / code info
- Lot #: J5J706, Exp. 10/31/2016
Why it was recalled
Non-Sterility: fungal contamination due to leaking containers.
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
- 57,408 units
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-03-25
- FDA classified
- 2016-10-12
- Posted by FDA
- 2016-10-19
- Terminated
- 2016-10-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0094-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.