Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit does cups (ba...
FDA Recall #D-0111-2021 — Class I — October 28, 2020
Product Description
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.
Recalling Firm
Lohxa LLC — Worcester, MA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
329 cartons
Distribution
Product was distributed to medical facilities in FL and NY.
Code Information
Lot #: T09101A, Exp 01/2021; T08292A, T10011A, Exp 02/2021; T10223A, M10193A, Exp 03/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated