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
Reported: December 9, 2020 Initiated: October 28, 2020 #D-0111-2021
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.
Details
- Recalling Firm
- Lohxa LLC
- Units Affected
- 329 cartons
- Distribution
- Product was distributed to medical facilities in FL and NY.
- Location
- Worcester, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Lohxa LLC. Units affected: 329 cartons.
Why was this product recalled? ▼
Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 9, 2020. Severity: Critical. Recall number: D-0111-2021.
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