SCA Pharmaceuticals Ketamine Injection Recall: Lack of Sterility Assurance
SCA Pharmaceuticals recalls Ketamine 50 mg/5 mL injection (NDC 70004-0430-09) due to lack of sterility assurance. This may cause infections if used improperly.
Lower-risk recall
Lack of Assurance of Sterility.
Contact the company
What happened, in plain English
SCA Pharmaceuticals is recalling a specific ketamine injection product because it lacks sterility assurance. This could lead to infections if the product is used without proper cleaning or sterilization. Read more at govinfonow.com/recall/38084-sca-pharmaceuticals-ketamine-injection-recall-lack-of-sterility-assurance.
Source Summary by GovInfoNow · govinfonow.com/recall/38084-sca-pharmaceuticals-ketamine-injection-recall-lack-of-sterility-assurance · Updated October 5, 2026 · FDA enforcement record: FDA #D-1843-2019
Cite this page
“SCA Pharmaceuticals Ketamine Injection Recall: Lack of Sterility Assurance.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38084-sca-pharmaceuticals-ketamine-injection-recall-lack-of-sterility-assurance. Based on FDA recall #D-1843-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1843-2019%22&limit=1).
Why it’s dangerous
The product lacks sterility assurance, meaning it could be contaminated with bacteria or other pathogens. If the injection is used without proper sterilization, it may cause infections in the patient.
Who’s affected
Prescription patients who received this specific ketamine injection product. Healthcare providers using the product for medical procedures are at higher risk.
How to tell if you have this one
Check for the product name 'Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection', NDC 70004-0430-09, and lot number 1219010961. This product was sold with an expiration date of 10/24/2019.
- Brand
SCA Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Verify the product name, NDC number 70004-0430-09, and lot number 1219010961 to confirm if you have the recalled item.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the U.S.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1843-2019 (August 16, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1843-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.