FDA Recall D-1160-2014
Baxter Healthcare Corp. · Deerfield, IL
Class I — life-threatening Terminated 1037 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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.
Reason for recall
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Recall record
- Recall number
D-1160-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- US Nationwide
- Recall initiated
- 2013-11-18
- Classified by FDA Center
- 2014-03-14
- FDA published
- 2014-03-26
- Terminated
- 2016-09-20
- Recalling firm
- Baxter Healthcare Corp.
- Firm location
- Deerfield, IL
Drug identification
- Brand name(s)
- CLINIMIX
- Generic name(s)
- LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DEXTROSE
- Manufacturer(s)
- Baxter Healthcare Corporation
- NDC(s)
0338-0180, 0338-1133, 0338-1089, 0338-1134, 0338-1091, 0338-1137, 0338-1099, 0338-1138, 0338-1101, 0338-0198, 0338-0188, 0338-0194, 0338-0184, 0338-7001, 0338-7003, 0338-7005, 0338-7007, 0338-7009, 0338-7011, 0338-7013, 0338-7015- Route(s)
- INTRAVENOUS