Recalls / Class II
Class IID-0301-2015
Product
Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL 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
- Product Code 2B7717 Lot # P311357, exp 12/31/2015
Why it was recalled
Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
Recalling firm
- Firm
- Baxter Healthcare Corp.
- Manufacturer
- Baxter Healthcare Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 7,220 bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-11-25
- FDA classified
- 2014-12-16
- Posted by FDA
- 2014-12-24
- Terminated
- 2015-10-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0301-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.