The Recall Desk
SevereFDA (Drugs)·D-1274-2014·Announced 2014-05-07

B. Braun Recalls ProcalAmine Injectable Due to Particulate Matter

B. Braun Medical Inc. is recalling ProcalAmine injectable products due to visible particulate matter found in reserve samples.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.

Plain-English summary

B. Braun Medical Inc. is recalling ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 mL containers. The recall affects 18,090 units of the prescription-only, sterile, single-dose product manufactured by B. Braun Medical Inc. in Irvine, California.

The recall was initiated because visible particulate matter was found in reserve sample units. The affected product is identified by Lot# J2K023 with an expiration date of 02/14. The product was distributed nationwide, as well as in Puerto Rico and Spain.

Healthcare providers and patients should stop using the affected product and contact B. Braun Medical Inc. for further instructions or replacement.

The recalled product

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
Manufacturer
B. Braun Medical Inc
Category
Drug — Injectable
Hazard
Affected units
18,090

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot# J2K023
  • Exp 02/14

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 12 recalled by B. Braun Medical Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

Related recalls

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Same hazard · particulate matter

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