Drug 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
D-0111-2021
Product summary
- Firm
- Lohxa LLC
- Event
- Event 86717
- Status
- Terminated
- Classification
- Class I
- Quantity
- 329 cartons
- Official record key
drug-enforcement:D-0111-2021
Official wording
Reason: Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata.
Code information: Lot #: T09101A, Exp 01/2021; T08292A, T10011A, Exp 02/2021; T10223A, M10193A, Exp 03/2021
Distribution pattern: Product was distributed to medical facilities in FL and NY.
Derived failure modes
-
Microbial contamination
Microbial contamination