6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a 1000 mL container, C...
FDA Recall #D-1271-2014 — Class I — November 21, 2013
Product Description
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.
Recalling Firm
B. Braun Medical Inc — Irvine, CA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
4614 units
Distribution
Nationwide, Puerto Rico and Spain
Code Information
Lot# J2H002, Exp 06/14; J2S018, Exp 12/14
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated