FDA-Drug2014-05-07Class I

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

B. Braun Medical Inc
Hazard

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

Sold states
Nationwide, Puerto Rico and Spain
Affected count
4614 units
Manufactured in
2525 McGaw Ave, Irvine, CA, United States
Products
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

Official notice

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

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