Recalls / Class II
Class IID-1542-2014
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.
- Brand name
- Prosol
- Generic name
- Valine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid And Tyrosine
- Active ingredients
- Alanine, Arginine, Aspartic Acid, Glutamic Acid, Glycine, Histidine, Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Proline, Serine, Threonine, Tryptophan, Tyrosine, Valine
- Route
- Intravenous
- NDC
- 0338-0499
- FDA application
- NDA020849
- Affected lot / code info
- Lot #: P306225, Exp 08/14
Why it was recalled
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).
Recalling firm
- Firm
- Baxter Healthcare Corp
- Manufacturer
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 6,204 bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-08-04
- FDA classified
- 2014-08-18
- Posted by FDA
- 2014-08-27
- Terminated
- 2015-06-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1542-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.