B. Braun Medical Inc
Product Description: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
Status:Ongoing
City:Irvine
State:CA
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Letter
Distribution Pattern:Nationwide, Puerto Rico and Spain
Classification:Class I
Product Quantity:18,288 units
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.
Recall Initiation Date:20131121
Report Date:20140507

Amino Acids

Amino Acids

Amino Acids Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

Administration of amino acids solutions at excessive rates or to patients with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma. Conservative doses of amino acids should be given to these patients, dictated by the nutritional status of the patient. Should symptoms of hyperammonemia develop, amino acid administration should be discontinued and the patient's clinical status re-evaluated.

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low.

Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Plenamine™ 15% is indicated as an amino acid (nitrogen) source in parenteral nutrition regimens. This use is appropriate when the enteral route is inadvisable, inadequate or not possible, as when:

—   Gastrointestinal absorption is impaired by obstruction, inflammatory disease or its complications, or antineoplastic therapy;

—   Bowel rest is needed because of gastrointestinal surgery or its complications such as ileus, fistulae or anastomotic leaks;

—   Tube feeding methods alone cannot provide adequate nutrition.

History

There is currently no drug history available for this drug.

Other Information

Plenamine™ 15% Amino Acids Injection in a Pharmacy Bulk Package is a sterile, clear, nonpyrogenic solution of essential and nonessential amino acids for intravenous infusion in parenteral nutrition following appropriate dilution.

Plenamine™ 15% in a Pharmacy Bulk Package is not for direct infusion. It is a sterile dosage form which contains several single doses for use in a pharmacy admixture program in the preparation of intravenous parenteral fluids.

Each 100 mL contains:

*
Acetate from Lysine Acetate, USP and acetic acid used for pH adjustment.
 Essential Amino Acids  
 Lysine (from Lysine Acetate, USP) 1.18 g
 Leucine, USP 1.04 g
 Phenylalanine, USP 1.04 g
 Valine, USP 960 mg
 Isoleucine, USP 749 mg
 Methionine, USP 749 mg
 Threonine, USP 749 mg
 Tryptophan, USP 250 mg
      
 Nonessential Amino Acids  
 Alanine, USP 2.17 g
 Arginine, USP 1.47 g
 Glycine, USP 1.04 g
 Histidine, USP 894 mg
 Proline, USP 894 mg
 Glutamic Acid 749 mg
 Serine, USP 592 mg
 Aspartic Acid, USP 434 mg
 Tyrosine, USP 39 mg
 Sodium Metabisulfite, NF added 30 mg
 Water for Injection, USP  qs
      
 Essential Amino Acids 6.7 g
 Nonessential Amino Acids 8.3 g
 Total Amino Acids 15.0 g
 Total Nitrogen 2.37 g
 Acetate* 151 mEq/L
 Osmolarity (calculated) 1383 mOsmol/L
 pH 5.6 (5.2–6.0)  

The formulas for the individual amino acids are as follows:

 Essential Amino Acids
 Lysine Acetate H2N(CH2)4CH(NH2)COOH•CH3COOH
 Leucine (CH3)2CHCH2CH(NH2)COOH
 Phenylalanine  Chemical Structure
 Valine (CH3)2CHCH(NH2)COOH
 Isoleucine CH3CH2CH(CH3)CH(NH2)COOH
 Methionine CH3S(CH2)2CH(NH2)COOH
 Threonine CH3CH(OH)CH(NH2)COOH
 Tryptophan  Chemical Structure
 Nonessential Amino Acids
 Alanine CH3CH(NH2)COOH
 Arginine H2NC(NH)NH(CH2)3CH(NH2)COOH
 Glycine H2NCH2COOH
 Histidine  Chemical Structure
 Proline  Chemical Structure
 Glutamic Acid HOOC(CH2)2CH(NH2)COOH
 Serine HOCH2CH(NH2)COOH
 Aspartic Acid HOOCCH2CH(NH2)COOH
 Tyrosine  Chemical Structure

Amino Acids Manufacturers


  • B. Braun Medical Inc.
    Amino Acids (Lysine Acetate, Leucine, Phenylalanine, Valine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Histidine, Proline, Glutamic Acid, Serine, Aspartic Acid, And Tyrosine) Solution [B. Braun Medical Inc.]

Login To Your Free Account