FDA Recall D-0856-2022

Fagron, Inc · Saint Paul, MN

Class I — life-threatening Completed 1532 days on record

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

Product

SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 51552-1123-9), Rx Only, Manufactured for Fagron, Inc., St. Paul, MN 55120.

Lot / code: Lot #: a) A67185, Exp. Date 08/31/2024; b) Lot #: A67186, Exp. Date 08/31/2024

Quantity: a) 559 bottles and b) 243 bottles

Reason for recall

Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.

Recall record

Recall number: D-0856-2022
Classification: Class I
Status: Completed
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide USA and Puerto Rico, Canada, Columbia, France
Recall initiated: 2022-03-04
Classified by FDA Center: 2022-05-09
FDA published: 2022-05-18
Recalling firm: Fagron, Inc
Firm location: Saint Paul, MN

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