The Recall Desk
SevereFDA (Drugs)·D-1271-2014·Announced 2014-05-07

B. Braun Recalls FreAmine HBC Injection Due to Particulate Matter

B. Braun Medical Inc. is recalling 6.9% FreAmine HBC (Amino Acid Injection) units 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 severity score of at least 4 per the rubric.

Plain-English summary

B. Braun Medical Inc. is recalling 6.9% FreAmine HBC (Amino Acid Injection), a sterile, single-dose, prescription-only injectable product. The recall involves partial fill containers of 750 mL in a 1000 mL container, identified by Catalog No. S9350-58SS and NDC 0264-9350-55.

The recall was initiated due to the presence of visible particulate matter found in reserve sample units. The affected lots are J2H002 (expiration 06/14) and J2S018 (expiration 12/14). A total of 4,614 units were distributed nationwide, in Puerto Rico, and in 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
6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a 1000 mL container, Catalog No. S9350-58SS, Sterile, Single dose container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-9350-55
Manufacturer
B. Braun Medical Inc
Category
Drug — Injectable
Hazard
Affected units
4,614

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 (4)

  • Lot# J2H002
  • Exp 06/14
  • J2S018
  • Exp 12/14

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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