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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

Rx Pak Division of McKesson Corporation: Docusate Sodium Recalled Due to Labeling Mix-up with Gabapentin

Agency Publication Date: March 15, 2019
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Summary

Approximately 29,622 blister cards of Docusate Sodium (100mg softgels) are being recalled because the outer carton may be incorrectly labeled as Gabapentin (300mg). This labeling error means that healthcare providers or patients might accidentally administer the wrong medication, which can lead to serious health complications or leave underlying conditions untreated. The affected medication was manufactured by Aenova Holding GmBh for Rx Pak Division of McKesson Corporation and was intended for institutional use only. These products were distributed to five major distributors across the United States.

Risk

A labeling mix-up on the secondary carton poses a risk of medication error. If a patient receives Docusate Sodium instead of prescribed Gabapentin, their seizures or nerve pain may go untreated; conversely, taking Gabapentin unintentionally could cause adverse drug reactions.

What You Should Do

  1. Check your inventory for Docusate Sodium 100mg softgels in 10 x 10 unit dose blister cards with NDC 63739-0478-10.
  2. Verify the lot number and expiration date on the packaging to see if they match Lot # 0119397 and Expiration 02/2020.
  3. Inspect the secondary carton (outer box) to see if it is incorrectly labeled as 'Gabapentin 300mg' instead of 'Docusate Sodium 100mg'.
  4. If you identify an affected product, contact your healthcare provider or pharmacist immediately for guidance on medication management.
  5. Return any unused product to the pharmacy or place of purchase for a refund and contact the manufacturer for further instructions.
  6. For more information or to report any adverse events, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

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

Affected Products

Product: Docusate Sodium, 100mg softgels, 10 x 10 unit dose blister cards
Model:
NDC 63739-0478-10
Recall #: D-1007-2019
Lot Numbers:
0119397 (Exp 02/2020)
Date Ranges: Expiration 02/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81943
Status: Resolved
Manufacturer: Rx Pak Division of McKesson Corporation
Sold By: Institutional distributors
Manufactured In: United States
Units Affected: 29,622 Blister Cards
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 · 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.