FDA Recall D-0299-2019

Fresenius Kabi USA, LLC · Grand Island, NY

Class I — life-threatening Terminated 1628 days on record

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

Product

SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-20, Product code 918620

Lot / code: Lot# EXP date: 6013062 11/2018 6014162 05/2019 6014163 05/2019 6014164 05/2019 6014377 06/2019 6014378 06/2019 6014379 06/2019 6016005 02/2020 6016071 02/2020 6016072 02/2020 6016073 02/2020 6017383 07/2020 6017384 07/2020 6017422 07/2020 6017423 07/2020 6017424 07/2020

Quantity: 1,312,350 20 mL vials

Reason for recall

Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.

Recall record

Recall number: D-0299-2019
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distributed Nationwide in the USA and Puerto RIco
Recall initiated: 2018-11-15
Classified by FDA Center: 2018-12-14
FDA published: 2018-12-12
Terminated: 2023-05-01
Recalling firm: Fresenius Kabi USA, LLC
Firm location: Grand Island, NY

Drug identification

Brand name(s): SODIUM CHLORIDE
Generic name(s): SODIUM CHLORIDE
Manufacturer(s): Fresenius Kabi USA, LLC
NDC(s): 63323-186
Route(s): INTRAVENOUS

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