Class I · High risk
Dextrose Injection
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Clinimix 5/15 sulfite-free
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
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
Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1099-04.
Affected NDC
0338-1099-04
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 |
|---|---|---|---|---|
| Clinimix Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose NDC 00338-1099 |
LEUCINE 365 mg/100mL; PHENYLALANINE 280 mg/100mL; LYSINE 290 mg/100mL; METHIONINE 200 mg/100mL; ISOLEUCINE 300 mg/100mL; VALINE 290 mg/100mL; HISTIDINE 240 mg/100mL; THREONINE 210 mg/100mL; TRYPTOPHAN 90 mg/100mL; ALANINE 1035 mg/100mL; GLYCINE 515 mg/100mL; ARGININE 575 mg/100mL; PROLINE 340 mg/100mL; SERINE 250 mg/100mL; TYROSINE 20 mg/100mL; DEXTROSE 15 g/100mL | Injection Intravenous |
Baxter Healthcare Corporation | Rx |
- Recalling firm
- Baxter Healthcare Corp.
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1160-2014 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. 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 2013 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 2013
All particulate / foreign matter recalls
Class II · Moderate risk
Carisoprodol Tablets
Presence of Foreign Substance; metal particulates were visually observed in the tablets.
Class I · High risk
Lidocaine HCl Injection
Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.
Class II · Moderate risk
Propofol Injectible Emulsion
Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded particulate matter which could result in the potential for small glass flakes or embedded metal particulate to become dislodged into the solution.
Class II · Moderate risk
Carisoprodol IV
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing.
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