FDA recall D-1274-2014

B. Braun Medical Inc · Class I · drug

Product

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.

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-1274-2014