December 2020 FDA Recall Drug by Sunstar Americas, Inc. (D-0222-2021 - cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions)

This Class II drug recall was voluntarily initiated by Sunstar Americas, Inc. on December 28, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations; fda inspection of manufacturing facility observed potential burkholderia cepacia complex (bcc) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0222-2021

Reason for Recall
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
Initiated
12-28-2020
Reported
01-20-2021
Quantity
a) 1,021,914 bottles; b) 255,552 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87052
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sunstar Americas, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Product Description About Product Description
Full technical description of the product.
Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumburg, IL

Batch or Lot Expiration Information

Lot# ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022