Why it was recalled
Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
Product description
Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 52376-021-04, Sunstar Americas, Inc.
Lot numbers, UPCs & expiration codes
Lot #: a) C170FY, C170FZ, C170GA, C170GB, C170GC, C177GP, C177GQ, C177GR, Exp 6/30/2022; C191KS, C191KT, C191KU, C191KW, C191KX, C191KY, C198LJ, C198LK, C198LL, C198LM, C205BH, C205BJ, C205BK, C205BL, C205BM, C205BN, Exp 7/31/2022; C219DK, C219DL, C219DM, C219DN, C219DP, C219DQ, C219DR, C219DS, Exp 8/31/2022; C240GM, C240GP, C240GQ, C240GR, Exp 9/30/2022; b) C191KR, Exp 7/31/2020
Where it was sold
USA Nationwide
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-0103-2021
- Classification
- Class I
- Status
- Completed
- Recall initiated
- Oct 27, 2020
- FDA report date
- Dec 2, 2020
- Quantity
- a) 116,662 bottles; b) 13,296 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sunstar Americas, Inc.
Original FDA data
Every field from FDA enforcement report D-0103-2021, exactly as published.
Show all FDA fields
- City
- Schaumburg
- State
- IL
- Status
- Completed
- Country
- United States
- Event ID
- 86656
- Address
- 301 E Central Rd
- Code information
- Lot #: a) C170FY, C170FZ, C170GA, C170GB, C170GC, C177GP, C177GQ, C177GR, Exp 6/30/2022; C191KS, C191KT, C191KU, C191KW, C191KX, C191KY, C198LJ, C198LK, C198LL, C198LM, C205BH, C205BJ, C205BK, C205BL, C205BM, C205BN, Exp 7/31/2022; C219DK, C219DL, C219DM, C219DN, C219DP, C219DQ, C219DR, C219DS, Exp 8/31/2022; C240GM, C240GP, C240GQ, C240GR, Exp 9/30/2022; b) C191KR, Exp 7/31/2020
- Postal code
- 60195-1901
- Report date
- Dec 2, 2020
- Product type
- Drugs
- Recall number
- D-0103-2021
- Classification
- Class I
- Recalling firm
- Sunstar Americas, Inc.
- Product quantity
- a) 116,662 bottles; b) 13,296 bottles
- Reason for recall
- Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 52376-021-04, Sunstar Americas, Inc.
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Oct 27, 2020
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Nov 23, 2020