Recalls / Class I
Class ID-0864-2016
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 E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injection Port Chamber 30% Dextrose Injection with Calcium, 1000 mL Outlet Port Chamber 10% Amino Acid Injection with Electrolytes, 2000 mL CLARITY Dual Chamber Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B7721, NDC 0338-1123-04.
- 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 #: P333930, Exp 05/31/2017
Why it was recalled
Presence of Particulate Matter: identified as dried skin.
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
- 7,436 bags
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-01-21
- FDA classified
- 2016-05-23
- Posted by FDA
- 2016-06-01
- Terminated
- 2018-02-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0864-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.