FDA Recall D-1489-2019

Fresenius Kabi USA, LLC · Melrose Park, IL

Class I — life-threatening Terminated 1180 days on record

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

Product

Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi, Lake Zurich, IL 60047. 63323-117-61 [Fresenius Kabi brand] and NDC 63323-117-69 [NOVAPLUS brand]

Lot / code: Lot 6120420 NDC 63323-117-61, Product Code 101761 and Lot 6120341 NDC 63323-117-69, Product Code NP101761

Quantity: 14,016 vials

Reason for recall

Presence of Particulate Matter; glass particulates

Recall record

Recall number: D-1489-2019
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide USA and Puerto Rico
Recall initiated: 2019-06-28
Classified by FDA Center: 2019-07-17
FDA published: 2019-07-24
Terminated: 2022-09-20
Recalling firm: Fresenius Kabi USA, LLC
Firm location: Melrose Park, IL

Drug identification

Brand name(s): FLUOROURACIL
Generic name(s): FLUOROURACIL
Manufacturer(s): Fresenius Kabi USA, LLC
NDC(s): 63323-117
Route(s): INTRAVENOUS

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