Why it was recalled
Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata.
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
Lot numbers, UPCs & expiration codes
Lot #: T09101A, Exp 01/2021; T08292A, T10011A, Exp 02/2021; T10223A, M10193A, Exp 03/2021
Where it was sold
Product was distributed to medical facilities in FL and NY.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0111-2021
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Oct 28, 2020
- FDA report date
- Dec 9, 2020
- Quantity
- 329 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lohxa LLC
Original FDA data
Every field from FDA enforcement report D-0111-2021, exactly as published.
Show all FDA fields
- City
- Worcester
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 86717
- Address
- 600 Main St Ste 110
- Code information
- Lot #: T09101A, Exp 01/2021; T08292A, T10011A, Exp 02/2021; T10223A, M10193A, Exp 03/2021
- Postal code
- 01608-2061
- Report date
- Dec 9, 2020
- Product type
- Drugs
- Recall number
- D-0111-2021
- Classification
- Class I
- Recalling firm
- Lohxa LLC
- Product quantity
- 329 cartons
- Termination date
- Mar 15, 2022
- Reason for recall
- Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed to medical facilities in FL and NY.
- Recall initiation date
- Oct 28, 2020
- Initial firm notification
- Letter
- Center classification date
- Nov 30, 2020