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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

SCA Pharmaceuticals, LLC: Ketamine Injection Recalled for Lack of Assurance of Sterility

Agency Publication Date: August 16, 2019
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Summary

SCA Pharmaceuticals, LLC is recalling 922 syringes of Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection (10 mg/mL concentration) because the product may not be sterile. This prescription medication is used for intravenous (IV) or intramuscular (IM) injection and was distributed nationwide in the United States. If a medication that is intended to be sterile is contaminated, it can cause serious, life-threatening infections in patients. Consumers should immediately stop using the affected syringes and contact their healthcare provider or pharmacist for further guidance.

Risk

The lack of sterility assurance means the injection could be contaminated with microorganisms. Injecting a non-sterile drug into a patient's body can lead to severe systemic infections, sepsis, and other life-threatening medical complications.

What You Should Do

  1. Check your medication for Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (10 mg/mL concentration) in 6 mL syringes.
  2. Verify the identifying codes on the syringe or packaging: look for NDC number 70004-0430-09, Lot number 1219010961, and an expiration date of 10/24/2019.
  3. If you identify an affected syringe, do not use it; contact your healthcare provider or pharmacist immediately for guidance on alternatives and safety.
  4. Return any unused product to the pharmacy or place of purchase for a refund and contact SCA Pharmaceuticals for further instructions.
  5. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund and contact the manufacturer for further instructions.

Affected Products

Product: Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (10 mg/mL concentration) 6 mL Syringe
Model:
NDC 70004-0430-09
Recall #: D-1843-2019
Lot Numbers:
1219010961 (Exp. 10/24/2019)
Date Ranges: 10/24/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83580
Status: Resolved
Manufacturer: SCA Pharmaceuticals, LLC
Sold By: hospitals; clinics; healthcare facilities
Manufactured In: United States
Units Affected: 922 syringes
Distributed To: Nationwide
Agency Last Updated: August 26, 2019

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.