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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

Akorn, Inc.: Acetylcysteine Injection Recalled for Manufacturing Deviations

Agency Publication Date: July 9, 2018
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Summary

Approximately 89,507 vials of Acetylcysteine for Injection (6 g/30 mL) have been recalled due to deviations from Current Good Manufacturing Practice (CGMP) standards. This prescription drug is used to treat paracetamol (acetaminophen) overdoses and to thin mucus in patients with certain lung conditions. While no specific injuries were reported in the data, the manufacturing issues may compromise the quality and safety of the medication. Consumers should verify if their medication matches the affected lot numbers and contact their healthcare provider immediately for instructions.

Risk

The recall was initiated due to manufacturing process failures (CGMP deviations) which could result in a product that does not meet safety or quality specifications. For an injectable medication, these deviations could lead to potential contamination or incorrect dosing, posing a moderate risk to patients requiring emergency treatment for overdoses or respiratory distress.

What You Should Do

  1. Check your medication packaging for Acetylcysteine for Injection 6 g/30 mL (200 mg/mL) with NDC 17478-660-30.
  2. Identify if your vial belongs to one of the affected lot numbers and expiration dates: Lot 061496A (Exp. 06/2018), Lot 111696A (Exp. 11/2018), Lot 061947A (Exp. 06/2019), or Lot 091267A (Exp. 09/2019).
  3. Contact your healthcare provider or pharmacist immediately for guidance if you have any of the affected vials in your possession.
  4. Return any unused or affected medication to the pharmacy or place of purchase for a refund.
  5. Contact Akorn, Inc. for further instructions regarding the return of the product or for any questions about this recall.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider consultation and pharmacy refund.

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

Affected Products

Product: Acetylcysteine for Injection (6 g/30 mL)
Model:
NDC 17478-660-30
Lot Numbers:
061496A (Exp. 06/2018)
111696A (Exp. 11/2018)
061947A (Exp. 06/2019)
091267A (Exp. 09/2019)
Date Ranges: Exp. 06/2018, Exp. 11/2018, Exp. 06/2019, Exp. 09/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80310
Status: Resolved
Manufacturer: Akorn, Inc.
Sold By: hospitals; pharmacies
Manufactured In: United States
Units Affected: 89,507 vials
Distributed To: Nationwide

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.