Sunstar Americas recalls
FDA enforcement reports naming Sunstar Americas, Inc. as the recalling firm.
- Recall reports
- 2
- Class I (serious)
- 1
- Most recent report
- Jan 20, 2021
- Jan 20, 2021Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0Drug · Sunstar Americas, Inc.cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditionsClass II
- Dec 2, 2020Paroex (chlorhexidine gluconate) Oral Rinse, USP 0Drug · Sunstar Americas, Inc.Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.Class I