Drug product
ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only, Baxter Healthcare Corporation, Clinitec Nutrition Division, Deerfield, IL 60015 USA, Product Code 2B6186, NDC 0338-0499-06.
D-1542-2014
Product summary
- Event
- Event 68963
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,204 bags
- Official record key
drug-enforcement:D-1542-2014
Official wording
Reason: Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine).
Code information: Lot #: P306225, Exp 08/14
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter