D-0111-2021 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 9, 2020
- Initiation Date
- October 28, 2020
- Termination Date
- March 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 329 cartons
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.
Distribution Pattern
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