Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported December 12, 2018
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
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…
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Fresenius Kabi USA, LLC recalled SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray,… - a critical-severity action.
SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray,… was recalled by Fresenius Kabi USA, LLC in December 12, 2018. Reason: Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the …. Check the official notice for the remedy. Verify recall #D-0299-2019 with the FDA Drug before acting.
The recall
Fresenius Kabi USA, LLC issued this critical-severity FDA Drug recall-Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the ….
- Critical
- severity level
- Class I
- classification
- December 12, 2018
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0299-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0299-2019) was formally reported on December 12, 2018, with the manufacturer initiating the action on November 15, 2018. It is classified under Critical severity (Class I), with a current status of Terminated. Fresenius Kabi USA, LLC is listed as the recalling firm, operating out of Grand Island, NY. Federal records list the affected scope as 1,312,350 20 mL vials.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: Distributed Nationwide in the USA and Puerto RIco. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1,312,350 20 mL vials
Related Recalls
6
5 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-0299-2019 |
| Date reported | December 12, 2018 |
| Date initiated | November 15, 2018 |
| Recalling firm | Fresenius Kabi USA, LLC |
| Firm location | Grand Island, NY |
| Affected scope | 1,312,350 20 mL vials |
| Distribution | Distributed Nationwide in the USA and Puerto RIco |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0299-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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.
Where was the recalled product distributed? ▼
Distribution: Distributed Nationwide in the USA and Puerto RIco.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0299-2019) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
FDA Drug Low
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fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3…
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FDA Drug Moderate
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported December 12, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.