Recalls / Class I
Class ID-1271-2014
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
6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a 1000 mL container, Catalog No. S9350-58SS, Sterile, Single dose container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-9350-55
- Affected lot / code info
- Lot# J2H002, Exp 06/14; J2S018, Exp 12/14
Why it was recalled
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Recalling firm
- Firm
- B. Braun Medical Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2525 McGaw Ave, Irvine, California 92614-5841
Distribution
- Quantity
- 4614 units
- Distribution pattern
- Nationwide, Puerto Rico and Spain
Timeline
- Recall initiated
- 2013-11-21
- FDA classified
- 2014-04-25
- Posted by FDA
- 2014-05-07
- Terminated
- 2014-12-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1271-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.