Recalls / Class I
Class ID-1158-2014
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 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.
- Brand name
- Clinimix E
- Generic name
- 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
- Active ingredients
- Alanine, Arginine, Calcium Chloride, Dextrose, Glycine, Histidine, Isoleucine, Leucine, Lysine, Magnesium Chloride, Methionine, Phenylalanine, Potassium Phosphate, Dibasic, Proline, Serine, Sodium Chloride, Threonine, Tryptophan, Tyrosine, Valine
- Route
- Intravenous
- NDCs
- 0338-0202, 0338-1142, 0338-1144, 0338-1113, 0338-1145, 0338-1115, 0338-1147, 0338-1123, 0338-1125, 0338-1148 +12 more
- FDA application
- NDA020678
- Affected lot / code info
- Lot#: P287045, Exp 6/2014
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 Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 14,574 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-1158-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.