Prescription mouthwash recalled because it may be contaminated with bacteria

Precision Dose, Inc. is voluntarily recalling prescription mouthwash because it was notified by the. maker, Sunstar Americas, that it can be contaminated with bacteria.

Chlorhexidine Gluconate Mouthwash USP, 0.12%, 15ml unit dose cups with an expiration date of January 31, 2021 through February 28, 2022, may be contaminated with Burkholderia lata, according to an announcement with the United States Food and Drug Administration.

The rinse is used to treat gingivitis and is only available with a prescription.

In healthy patients, flushing “can lead to oral and potentially systemic infections requiring antibacterial therapy.”

In populations most at risk, use of the defective product can lead to life-threatening infections, such as pneumonia and bacteremia. To date, no adverse events have been reported to Precision Dose, Inc. related to this recall.

The mouthwash was distributed in cases containing either three shrink-wrapped plastic trays with 10 unit dose cups (NDC number 68094-028-62) or cases with 10 shrink-wrapped plastic trays each containing 10 single cups (NDC number 68094-028 -61).

The products concerned are:

Lot number 502037, expiration date January 31, 2021, NDC numbers 68094-028-61 and 68094-028-62.

Lot number 502040, expiration date January 31, 2021, NDC numbers 68094-028-61 and 68094-028-62.

Lot number 502043, expiration date January 31, 2021, NDC numbers 68094-028-61 and 68094-028-62.

Lot number 502494, expiration date August 31, 2021, NDC numbers 68094-028-61 and 68094-028-62.

Batch number 502757, expiration date August 31, 2021, NDC number 68094-028-61.

Lot number 502677, expiration date September 30, 2021, NDC number 68094-028-61.

Lot number 502693, expiration date October 31, 2021, NDC number 68094-028-61.

Batch number 502728, expiration date October 31, 2021, NDC number 68094-028-61.

Lot number 502759, expiration date October 31, 2021, NDC number 68094-028-62.

Lot number 502771, expiration date November 30, 2021, NDC numbers 68094-028-61 and 68094-028-62.

Batch number 502784, expiration date November 30, 2021, NDC number 68094-028-61.

Lot number 502824, expiration date December 31, 2021, NDC number 68094-028-61.

Lot number 502925, expiration date February 28, 2022, NDC number 68094-028-61.

For more information, contact Precision Dose at 800-397-9228 between 8:00 a.m. and 4:30 p.m. CT weekdays or email [email protected]se.com.

READ MORE

Source link

About Armand Downs

Check Also

26-year-old Kalamazoo man faces federal drug and weapons charges after ‘controlled purchase’ of crack cocaine

KALAMAZOO, MI – A man from Kalamazoo arrested last summer for allegedly threatening to kill …

Leave a Reply

Your email address will not be published. Required fields are marked *