FDA Recall D-0103-2021

Sunstar Americas, Inc. · Schaumburg, IL

Class I — life-threatening Completed 2025 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 52376-021-04, Sunstar Americas, Inc.

Lot / code: Lot #: a) C170FY, C170FZ, C170GA, C170GB, C170GC, C177GP, C177GQ, C177GR, Exp 6/30/2022; C191KS, C191KT, C191KU, C191KW, C191KX, C191KY, C198LJ, C198LK, C198LL, C198LM, C205BH, C205BJ, C205BK, C205BL, C205BM, C205BN, Exp 7/31/2022; C219DK, C219DL, C219DM, C219DN, C219DP, C219DQ, C219DR, C219DS, Exp 8/31/2022; C240GM, C240GP, C240GQ, C240GR, Exp 9/30/2022; b) C191KR, Exp 7/31/2020

Quantity: a) 116,662 bottles; b) 13,296 bottles

Reason for recall

Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.

Recall record

Recall number: D-0103-2021
Classification: Class I
Status: Completed
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: USA Nationwide
Recall initiated: 2020-10-27
Classified by FDA Center: 2020-11-23
FDA published: 2020-12-02
Recalling firm: Sunstar Americas, Inc.
Firm location: Schaumburg, IL

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