FDA Recall D-0222-2021

Sunstar Americas, Inc. · Schaumburg, IL

Class II Ongoing 1963 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

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

Quantity: a) 1,021,914 bottles; b) 255,552 bottles

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

Recall record

Recall number: D-0222-2021
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: Nationwide USA
Recall initiated: 2020-12-28
Classified by FDA Center: 2021-01-11
FDA published: 2021-01-20
Recalling firm: Sunstar Americas, Inc.
Firm location: Schaumburg, IL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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