Class I · High risk
Dextrose Injection
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
10% Premasol sulfite-free
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA, NDC 0338-1130-06
Affected NDC
0338-1130-06
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 |
|---|---|---|---|---|
| Premasol - sulfite-free (Amino Acid) Leucine, Lysine, Isoleucine, Valine, Histidine, Phenylalanine, Threonine, Methionine, Tryptophan, Tyrosine, N-Acetyl-Tyrosine, Arginine, Proline, Alanine, Glutamic Acide, Serine, Glycine, Aspartic Acid, Taurine, Cysteine Hydrochloride NDC 00338-1130 |
LEUCINE 1.4 g/100mL; LYSINE ACETATE .82 g/100mL; ISOLEUCINE .82 g/100mL; VALINE .78 g/100mL; HISTIDINE .48 g/100mL; PHENYLALANINE .48 g/100mL; THREONINE .42 g/100mL; METHIONINE .34 g/100mL; TRYPTOPHAN .2 g/100mL; TYROSINE .24 g/100mL; ARGININE 1.2 g/100mL; PROLINE .68 g/100mL; ALANINE .54 g/100mL; GLUTAMIC ACID .5 g/100mL; SERINE .38 g/100mL; GLYCINE .36 g/100mL; ASPARTIC ACID .32 g/100mL; TAURINE 25 mg/100mL; CYSTEINE HYDROCHLORIDE .016 g/100mL | Injection, Solution Intravenous |
Baxter Healthcare Company | Rx |
- Recalling firm
- Baxter Healthcare Corporation
- NDC code
- 0338-1130-06
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0425-2017 · 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 Corporation
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 failed specification recalls from 2016
All failed specification recalls
Class III · Low risk
Finasteride Tablets
Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.
Class II · Moderate risk
Venlafaxine Hydrochloride extended release capsules
Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
Class II · Moderate risk
Furosemide Tablets USP
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Class II · Moderate risk
Lisinopril tablets
Failed tablet/capsule specification: missing break line on the 5mg tablet.
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