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
Reported: January 18, 2017 Initiated: December 6, 2016 #D-0425-2017
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.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 3,528 eaches
- Distribution
- US
- Location
- Deerfield, IL
Frequently Asked Questions
What product 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. Recalled by Baxter Healthcare Corporation. Units affected: 3,528 eaches.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 18, 2017. Severity: Moderate. Recall number: D-0425-2017.
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