FDA Recall D-0111-2021
Lohxa LLC · Worcester, MA
Class I — life-threatening Terminated 503 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit does cups (barcode 7016602715), packaged in 50-count unit dose cups per carton, Rx only, Distributed by: Lohxa, Worcester, MA 01608, NDC 70166-027-15
Reason for recall
Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata.
Recall record
- Recall number
D-0111-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Product was distributed to medical facilities in FL and NY.
- Recall initiated
- 2020-10-28
- Classified by FDA Center
- 2020-11-30
- FDA published
- 2020-12-09
- Terminated
- 2022-03-15
- Recalling firm
- Lohxa LLC
- Firm location
- Worcester, MA