FDAFDA · Food and drugs·Recall number D-1274-2014
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
Published May 7, 2014 · Recall initiated: November 21, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- B. Braun Medical Inc
- Distributor
- Nationwide, Puerto Rico and Spain
- Lot
- Lot# J2K023, Exp 02/14
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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