PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: December 12, 2018 Initiated: November 15, 2018 #D-0299-2019

Product Description

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

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.

Details

Recalling Firm
Fresenius Kabi USA, LLC
Units Affected
1,312,350 20 mL vials
Distribution
Distributed Nationwide in the USA and Puerto RIco
Location
Grand Island, NY

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Fresenius Kabi USA, LLC. Units affected: 1,312,350 20 mL vials.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 12, 2018. Severity: Critical. Recall number: D-0299-2019.

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