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
Reported: May 7, 2014 Initiated: November 21, 2013 #D-1274-2014
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.
Details
- Recalling Firm
- B. Braun Medical Inc
- Units Affected
- 18,090 units
- Distribution
- Nationwide, Puerto Rico and Spain
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by B. Braun Medical Inc. Units affected: 18,090 units.
Why was this product recalled? ▼
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 7, 2014. Severity: Critical. Recall number: D-1274-2014.
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