FDA-Drug2018-12-12Class I
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
Fresenius Kabi USA, LLC
Hazard
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.
Sold states
Distributed Nationwide in the USA and Puerto RIco
Affected count
1,312,350 20 mL vials
Manufactured in
3159 Staley Rd, N/A, Grand Island, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0299-2019Don't want to check this manually?
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