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Prescription Mouth Rinse Recalled


January 21, 2021

Precision Dose Inc. is recalling more than 1 million unit dose cups of chlorhexidine gluconate oral rinse 0.12% because of deviations from Current Good Manufacturing Practice regulations, according to the January 20, 2021, US Food and Drug Administration (FDA) Enforcement Report.

The recall includes 15-mL cups of chlorhexidine gluconate oral rinse 0.12% (NDC 68094-028-61, NDC 68094-028-62) packaged in the following:

  • 30-pack cases from lots 502037, 502040, and 502043 (Exp. 1/31/21); 502494 and 502757 (Exp. 8/31/21); 502677 (Exp. 9/30/21); 502693 and 502728 (Exp. 10/31/21); 502771 and 502784 (Exp. 11/30/21); 502824 (Exp. 12/31/21); and 502925 (Exp. 2/28/22); and
  • 100-pack cases from lots 502037, 502040, and 502043 (Exp 1/31/21); 502494 (Exp. 8/31/21); 502759 (Exp. 10/31/21); and 502771 (Exp 11/30/21). 

Precision Dose voluntarily initiated the recall January 1, 2021. The FDA designated the recall Class II on January 14, 2021. Use of a product under a Class II recall could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.

Chlorhexidine gluconate oral rinse 0.12% is a prescription oral rinse used to treat gingivitis.

Jolynn Tumolo

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