FDA recall D-1271-2014

B. Braun Medical Inc · Class I · drug

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

Reason for recall

Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

Distribution

Nationwide, Puerto Rico and Spain

Key facts

Status: Terminated
Initiation date: 2013-11-21
Report date: 2014-05-07
Termination date: 2014-12-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1271-2014