FDA recall D-0299-2019

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

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.

Distribution

Distributed Nationwide in the USA and Puerto RIco

Key facts

Status

Terminated

Initiation date

2018-11-15

Report date

2018-12-12

Termination date

2023-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Grand Island, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0299-2019