D-0425-2017 Class II Terminated
FDA drug recall D-0425-2017 was initiated by Baxter Healthcare Corporation on Dec 6, 2016 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Mar 26, 2018). Affected quantity: 3,528 eaches.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 18, 2017
- Initiation Date
- Dec 6, 2016
- Termination Date
- Mar 26, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,528 eaches
Product Description
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
Reason for Recall
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.
Distribution Pattern
US
Code Information
Lot #: P333617, Exp 4/30/17
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0425-2017
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026