Why it was recalled
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
Product description
Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumburg, IL
Lot numbers, UPCs & expiration codes
ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022
Where it was sold
Nationwide USA
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-0222-2021
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 28, 2020
- FDA report date
- Jan 20, 2021
- Quantity
- a) 1,021,914 bottles; b) 255,552 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sunstar Americas, Inc.
Original FDA data
Every field from FDA enforcement report D-0222-2021, exactly as published.
Show all FDA fields
- City
- Schaumburg
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 87052
- Address
- 301 E Central Rd
- Code information
- ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022
- Postal code
- 60195-1901
- Report date
- Jan 20, 2021
- Product type
- Drugs
- Recall number
- D-0222-2021
- Classification
- Class II
- Recalling firm
- Sunstar Americas, Inc.
- Product quantity
- a) 1,021,914 bottles; b) 255,552 bottles
- Reason for recall
- cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumburg, IL
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Dec 28, 2020
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jan 11, 2021