SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial
Medicine recall D-0298-2019. Published in FDA’s Enforcement Report on Dec 12, 2018.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 12, 2018. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 23,745,300 10 mL vials how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
23,745,300 10 mL vials, in FDA’s words.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot# EXP date: 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…
Every code shown here, 1,999 characters
Lot# EXP date: 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 6014260 05/2019 6014301 05/2019 6014302 05/2019 6014303 06/2019 6014304 06/2019 6014305 06/2019 6014306 06/2019 6014307 06/2019 6014384 06/2019 6014404 06/2019 6014405 06/2019 6014453 06/2019 6014454 06/2019 6014455 06/2019 6014479 06/2019 6014557 07/2019 6014558 07/2019 6014606 07/2019 6014649 08/2019 6014650 08/2019 6014704 08/2019 6014766 08/2019 6014767 08/2019 6014768 08/2019 6014841 08/2019 6014842 08/2019 6014843 08/2019 6014861 08/2019 6014862 08/2019 6014863 08/2019 6015049 09/2019 6015050 09/2019 6015088 09/2019 6015118 10/2019 6015127 10/2019 6015128 10/2019 6015186 10/2019 6015187 10/2019 6015188 10/2019 6015233 10/2019 6015234 10/2019 6015235 10/2019 6015285 11/2019 6015286 11/2019 6015287 11/2019 6015408 11/2019 6015409 11/2019 6015410 11/2019 6015452 11/2019 6015453 11/2019 6015454 11/2019 6015572 11/2019 6015573 12/2019 6015574 12/2019 6015616 12/2019 6015617 12/2019 6015618 12/2019 6015922 01/2020 6015923 01/2020 6015924 01/2020 6016002 02/2020 6016003 02/2020 6016004 02/2020 6016077 02/2020 6016104 02/2020 6016208 02/2020 6016209 02/2020 6016210 02/2020 6016258 02/2020 6016259 02/2020 6016260 02/2020 6016261 02/2020 6016262 03/2020 6016263 03/2020 6016264 03/2020 6016323 03/2020 6016324 03/2020 6016325 03/2020 6016383 03/2020 6016384 03/2020 6016385 03/2020 6016386 03/2020 6016387 03/2020 6016388 03/2020 6016389 03/2020 6016584 04/2020 6016585 04/2020 6016621 04/2020 6016622 04/2020 6016623 04/2020 6016765 05/2020 6016766 05/2020 6016767 05/2020 6016768 05/2020…
FDA’s list runs to 4,469 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Barcodes and drug codes
-
NDC
63323-186-10
As FDA’s description and codes give them; the UPCs written as digits only.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Distributed Nationwide in the USA and Puerto RIco
The states and territories these words name
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 15, 2018.
- FDA classified it on Dec 14, 2018.
- FDA’s Enforcement Report published it on Dec 12, 2018.
- FDA terminated it on May 1, 2023.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Fresenius Kabi USA, LLC, of Grand Island, NY.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,469 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Drug recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.