FDA Recall D-1158-2014
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 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1115-04.
Reason for recall
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Recall record
- Recall number
D-1158-2014- 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 E
- Generic name(s)
- LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE
- Manufacturer(s)
- Baxter Healthcare Company
- NDC(s)
0338-0202, 0338-1142, 0338-1144, 0338-1113, 0338-1145, 0338-1115, 0338-1147, 0338-1123, 0338-1125, 0338-1148, 0338-0206, 0338-0210, 0338-0214, 0338-7020, 0338-7022, 0338-7024, 0338-7026, 0338-7028, 0338-7030, 0338-7032, 0338-7034, 0338-7036- Route(s)
- INTRAVENOUS