ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 mL Container, Rx Onl...
FDA Recall #D-1274-2014 — Class I — November 21, 2013
Product Description
ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 mL Container, Rx Only, Catalog No. S9050, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1915-07
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
18,090 units
Distribution
Nationwide, Puerto Rico and Spain
Code Information
Lot# J2K023, Exp 02/14
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated