Recalls / Class II
Class IID-0425-2017
Product
10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA, NDC 0338-1130-06
- Brand name
- Premasol - Sulfite-free (amino Acid)
- Generic name
- Leucine, Lysine, Isoleucine, Valine, Histidine, Phenylalanine, Threonine, Methionine, Tryptophan, Tyrosine, N-acetyl-tyrosine, Arginine, Proline, Alanine, Glutamic Acide, Serine, Glycine, Aspartic Acid, Taurine, Cysteine Hydrochloride
- Active ingredients
- Alanine, Arginine, Aspartic Acid, Cysteine Hydrochloride, Glutamic Acid, Glycine, Histidine, Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Proline, Serine, Taurine, Threonine, Tryptophan, Tyrosine, Valine
- Route
- Intravenous
- NDCs
- 0338-1130, 0338-1131
- FDA application
- ANDA075880
- Affected lot / code info
- Lot #: P333617, Exp 4/30/17
Why it was recalled
Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Manufacturer
- Baxter Healthcare Company
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 3,528 eaches
- Distribution pattern
- US
Timeline
- Recall initiated
- 2016-12-06
- FDA classified
- 2017-01-09
- Posted by FDA
- 2017-01-18
- Terminated
- 2018-03-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0425-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.