Prescription mouthwash recall because it may be contaminated with bacteria
Sunstar Americas is recalling Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12% products from the marketplace where they may be contaminated with burkholderia lata.
The rinse is only available with a prescription from healthcare professionals. According to a press release from Sunstar, it is used to treat gingivitis.
The use of cold rinsing causes infections. In those at risk, flushing can lead to pneumonia and bacteremia. There have been no reports of “adverse events”.
The products are:
- 1789P GUM Paroex is supplied in cases each containing 6 16 fluid ounce (473 mL) amber bottles of chlorhexidine rinse. The bottle has a child-resistant cap and 15ml measuring cup, is securely sealed and decorated with a multi-panel wrap-around label.
- 1788P GUM Paroex is supplied in cases each containing 24 4 fluid ounce (118.25 mL) amber bottles of chlorhexidine rinse. The bottle has a child resistant cap, is security sealed and is decorated with a multi-panel wrap-around label.
Paroex has been distributed nationwide to dental offices, dental distributors, pharmaceutical wholesalers, dental schools and pharmacies.
The lot numbers of the recalled products and the expiration dates are:
- C170FY, C120FZ, C170GB, C170GC, C177GP, C177GQ and C177GR, June 30, 2022.
- C240GP, C249GQ and C240GR, September 30, 2022.
- C191KS, C191KT, C191KU, C191KW, C191KY, C198LJ, C198LK, C198LL, C198LM, C205BH, C205BJ, C205 BK, C205BL, C25BM and C205BN, July 31, 2022.
- C219DS, August 31, 2022.
- C240GM, September 30, 2022.
- C219DK, C219DL, C219DM, C219DN, C219DP, C219DQ and C219DR, August 31, 2022.
The company gave no information on how the potential contamination could have occurred.
For more information, call Sunstar Americas at 800-528-8537 between 8:00 a.m. and 5:00 p.m. CST, weekdays or email [email protected] during the same hours.
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