Class I · High risk
Dextrose Injection
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
CLINIMIX E 5/15 sulfite-free
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: identified as dried skin.
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 E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injection Port Chamber 30% Dextrose Injection with Calcium, 1000 mL Outlet Port Chamber 10% Amino Acid Injection with Electrolytes, 2000 mL CLARITY Dual Chamber Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B7721, NDC 0338-1123-04.
Affected NDC
0338-1123-04
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 00338-1123 |
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; SODIUM ACETATE 340 mg/100mL; POTASSIUM PHOSPHATE, DIBASIC 261 mg/100mL; MAGNESIUM CHLORIDE 51 mg/100mL; SODIUM CHLORIDE 59 mg/100mL; CALCIUM CHLORIDE 33 mg/100mL; DEXTROSE 15 g/100mL | Injection Intravenous |
Baxter Healthcare Company | Rx |
- Recalling firm
- Baxter Healthcare Corp.
- NDC code
- 0338-1123-04
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0864-2016 · 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 2016 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 2016
All particulate / foreign matter recalls
Class III · Low risk
Pentasa (mesalamine)
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Class II · Moderate risk
Metformin Hydrochloride Tablets
Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
Class III · Low risk
AHP NIFEdipine Capsules
Presence of Foreign Tablets/Capsules
Class III · Low risk
NIFEdipine Capsules USP
Presence of Foreign Tablets/Capsules
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