Class I · High risk
Dextrose Injection
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
ProSol - sulfite-free
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine).
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only, Baxter Healthcare Corporation, Clinitec Nutrition Division, Deerfield, IL 60015 USA, Product Code 2B6186, NDC 0338-0499-06.
Affected NDC
0338-0499-06
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| ProSol Valine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid and Tyrosine NDC 00338-0499 |
VALINE 1.44 g/100mL; LYSINE ACETATE 1.35 g/100mL; HISTIDINE 1.18 g/100mL; ISOLEUCINE 1.08 g/100mL; LEUCINE 1.08 g/100mL; PHENYLALANINE 1 g/100mL; THREONINE 980 mg/100mL; METHIONINE 760 mg/100mL; TRYPTOPHAN 320 mg/100mL; ALANINE 2.76 g/100mL; GLYCINE 2.06 g/100mL; ARGININE 1.96 g/100mL; PROLINE 1.34 g/100mL; GLUTAMIC ACID 1.02 g/100mL; SERINE 1.02 g/100mL; ASPARTIC ACID 600 mg/100mL; TYROSINE 50 mg/100mL | Injection, Solution Intravenous |
Baxter Healthcare Corporation | Rx |
- Recalling firm
- Baxter Healthcare Corp
- NDC code
- 0338-0499-06
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1542-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Baxter Healthcare Corp
All 2014 recalls
Class I · High risk
0.9% Sodium Chloride Injection USP 500 mL
Presence of particulate matter: Particulates identified as fiberglass
Class II · Moderate risk
Daptomycin
CGMP Deviations
Class II · Moderate risk
Vancomycin Injection
CGMP Deviations
Other particulate / foreign matter recalls from 2014
All particulate / foreign matter recalls
Class II · Moderate risk
Children's Loratadine Syrup
Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Class II · Moderate risk
Hydroxocobalamin Injection Solution 1 mg/mL Inj.
Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product
Class I · High risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.