The Recall Desk

FDA (Drugs) recall action 66913

B. Braun Medical Inc recalled 12 products on 2014-05-07

The FDA (Drugs) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.

Products
12
Announced
2014-05-07
Critical
2
Units
375,198

Why these products were recalled

Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–12 of 12

  • SevereFDA (Drugs)··2014-05-07

    B. Braun Recalls 15% Amino Acids Injection Due to Particulate Matter

    B. Braun Medical Inc. is recalling 15% Amino Acids Injection products due to visible particulate matter found in reserve sample units.

    Product
    15% Amino Acids Injection PBP Glass, 1000 mL, Catalog No. S3200-SS, Pharmacy Bulk Package, Not For Direct Infusion, For Intravenous Use, Sterile, Single Dose Container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-3200-55
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-05-07

    B. Braun Recalls Ceftriaxone Injection Due to Particulate Matter

    B. Braun Medical Inc. is recalling Ceftriaxone for Injection and Dextrose Injection due to visible particulate matter found in reserve sample units.

    Product
    Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog Number 3153-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-05-07

    B. Braun Recalls Hyperlyte CR Injectable Due to Particulate Matter

    B. Braun Medical Inc. is recalling Hyperlyte CR injectable products because visible particulate matter was found in reserve sample units.

    Product
    Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No. S9432, Rx Only, Sterile, B Braun Medical Inc., Irvine CA 92614-5895, In Canada Dist by: B Braun Medical Inc., Scarborough, Ontario M1H 2W4, NDC 0264-1943-20, Canada DIN 01924311
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-05-07

    B. Braun Recalls Cefepime Injection Due to Visible Particulate Matter

    B. Braun Medical Inc. is recalling Cefepime Hydrochloride and Dextrose injection units because visible particulate matter was found in reserve samples.

    Product
    CEFEPIME HYDROCHLORIDE AND DEXTROSE (CEFEPIME HYDROCHLORIDE)
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-05-07

    B. Braun Recalls Sodium Chloride Injection Due to Particulate Matter

    B. Braun Medical Inc. is recalling 0.9% Sodium Chloride Injection USP due to visible particulate matter found in reserve samples.

    Product
    0.9 % Sodium Chloride Injection USP, 1000 mL, Catalog No. S4000-SS, Rx Only, Sterile, Single Dose Container, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-4000-55
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··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.

    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
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··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.

    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
    Category
    Distribution
    1 state
  • CriticalFDA (Drugs)··2014-05-07

    B. Braun Recalls TrophAmine Injection Due to Particulate Matter

    B. Braun Medical Inc. is recalling TrophAmine (10% Amino Acid Injection) units due to visible particulate matter found in reserve samples.

    Product
    TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No. S9341-SS, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-9341-55
    Category
    Distribution
    1 state