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

FDA recall notice · announced December 9, 2020 · Lohxa

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Notes

Distribution: Product was distributed to medical facilities in FL and NY.
Lot/code information: Lot #: T09101A, Exp 01/2021; T08292A, T10011A, Exp 02/2021; T10223A, M10193A, Exp 03/2021
Quantity: 329 cartons
Status: Terminated
Products in this recall event:
- 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, Worc (D-0111-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.