Reported Dec 2, 2020 · Completed
Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC…
Sunstar Americas, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sunstar Americas, Inc. · 301 E Central Rd · Schaumburg, IL · 60195-1901
Is this the product you have?
- Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only
- packaged ina) 1 pint (473 mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 52376-021-04, Sunstar Americas, Inc
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 C170FY, C170FZ, C170GA, C170GB, C170GC, C177GP, C177GQ, C177GR, Exp 6/30/2022 2 C191KS, C191KT, C191KU, C191KW, C191KX, C191KY, C198LJ, C198LK, C198LL, C198LM, C205BH, C205BJ, C205BK, C205BL, C205BM, C205BN, Exp 7/31/2022 3 C219DK, C219DL, C219DM, C219DN, C219DP, C219DQ, C219DR, C219DS, Exp 8/31/2022 4 C240GM, C240GP, C240GQ, C240GR, Exp 9/30/2022 5 C191KR, Exp 7/31/2020 - Amount recalled
- a) 116,662 bottles; b) 13,296 bottles
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Sunstar Americas, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.