Reported Dec 12, 2018 · Terminated

SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals,…

Fresenius Kabi USA, LLC

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Fresenius Kabi USA, LLC · 3159 Staley Rd · Grand Island, NY · 14072-2028

Is this the product you have?

SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-10 Product code 918610

Lot codes and dates: Lot#
EXP date
328 of 328 codes
6013112
11/2018
6013113
11/2018
6013114
11/2018
6013180
11/2018
6013181
11/2018
6013182
11/2018
6013237
01/2019
6013238
01/2019
6013239
01/2019
6013468
02/2019
6013512
02/2019
6013513
02/2019
6013551
02/2019
6013552
02/2019
6013553
02/2019
6013607
02/2019
6013608
02/2019
6013610
02/2019
6013627
03/2019
6013678
03/2019
6013679
03/2019
6013822
03/2019
6013823
03/2019
6013824
03/2019
6013924
04/2019
6013925
04/2019
6013926
04/2019
6014003
05/2019
6014004
05/2019
6014005
05/2019
non US
228 of 228 codes
6013112
11/2018
6013113
11/2018
6013114
11/2018
6013180
11/2018
6013181
11/2018
6013182
11/2018
6013237
01/2019
6013238
01/2019
6013239
01/2019
6013468
02/2019
6013512
02/2019
6013513
02/2019
6013551
02/2019
6013552
02/2019
6013553
02/2019
6013607
02/2019
6013608
02/2019
6013610
02/2019
6013627
03/2019
6013678
03/2019
6013679
03/2019
6013822
03/2019
6013823
03/2019
6013824
03/2019
6013924
04/2019
6013925
04/2019
6013926
04/2019
6014003
05/2019
6014004
05/2019
6014005
05/2019
Amount recalled: 23,745,300 10 mL vials

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit…

Where it was sold

Nationwide
PR

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

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57 in total.

Where it was distributed

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