Drug product
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
D-0425-2017
Product summary
- Event
- Event 75835
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,528 eaches
- Official record key
drug-enforcement:D-0425-2017
Official wording
Reason: 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.
Code information: Lot #: P333617, Exp 4/30/17
Distribution pattern: US
Derived failure modes
-
Unknown
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.