Recalls / Class I
Class ID-1160-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1099-04.
- Brand name
- Clinimix
- Generic name
- Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose
- Active ingredients
- Alanine, Arginine, Dextrose, Glycine, Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Proline, Serine, Threonine, Tryptophan, Tyrosine, Valine
- Route
- Intravenous
- NDCs
- 0338-0180, 0338-1133, 0338-1089, 0338-1134, 0338-1091, 0338-1137, 0338-1099, 0338-1138, 0338-1101, 0338-0198 +11 more
- FDA application
- NDA020734
- Affected lot / code info
- Lot# P285122, Exp 5/2014
Why it was recalled
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
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
- 7,388 bags
- Distribution pattern
- US Nationwide
Timeline
- Recall initiated
- 2013-11-18
- FDA classified
- 2014-03-14
- Posted by FDA
- 2014-03-26
- Terminated
- 2016-09-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1160-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.