Class I · High risk
Dextrose Injection
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Clinimix E 4.25/10 sulfite-free
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-1115-04
Affected NDC
0338-1115-04
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 E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose NDC 00338-1115 |
LEUCINE 311 mg/100mL; PHENYLALANINE 238 mg/100mL; LYSINE 247 mg/100mL; METHIONINE 170 mg/100mL; ISOLEUCINE 255 mg/100mL; VALINE 247 mg/100mL; HISTIDINE 204 mg/100mL; THREONINE 179 mg/100mL; TRYPTOPHAN 77 mg/100mL; ALANINE 880 mg/100mL; GLYCINE 438 mg/100mL; ARGININE 489 mg/100mL; PROLINE 289 mg/100mL; SERINE 213 mg/100mL; TYROSINE 17 mg/100mL; SODIUM ACETATE 297 mg/100mL; POTASSIUM PHOSPHATE, DIBASIC 261 mg/100mL; MAGNESIUM CHLORIDE 51 mg/100mL; SODIUM CHLORIDE 77 mg/100mL; CALCIUM CHLORIDE 33 mg/100mL; DEXTROSE 10 g/100mL | Injection Intravenous |
Baxter Healthcare Company | Rx |
- Recalling firm
- Baxter Healthcare Corp.
- NDC code
- 0338-1115-04
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0301-2015 · 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 sterility / contamination recalls from 2014
All sterility / contamination recalls
Class II · Moderate risk
Virazole (Ribavirin for Inhalation Solution, USP)
Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.
Class II · Moderate risk
Total parenteral nutrition various strengths
Lack of sterility assurance.
Class II · Moderate risk
L-cysteine various strengths
Lack of sterility assurance.
Class II · Moderate risk
Immune globulin g human various strengths
Lack of sterility assurance.
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