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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Asclemed USA Inc. dba Enovachem Pharmaceuticals: Methylprednisolone Tablets Recalled Due to Illegible Dosing Instructions

Agency Publication Date: April 12, 2021
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Summary

Asclemed USA Inc. (dba Enovachem Pharmaceuticals) is recalling specific lots of Methylprednisolone Tablets USP 4 mg (21-count blister cards) because the printed dosing instructions on the packaging may be misaligned or illegible. This recall affects medication distributed by DocRx and relabeled by Enovachem Pharmaceuticals. Because these instructions guide how a patient should taper their dosage, incorrect or unreadable directions could lead to improper medication use. Consumers should contact their healthcare provider or pharmacist immediately to discuss their treatment and how to obtain a legible replacement.

Risk

The misaligned print makes the critical dosing instructions on the blister card difficult or impossible to read. This poses a risk that patients may take the wrong amount of medication, which is particularly dangerous for steroids like methylprednisolone that require precise tapering of doses.

What You Should Do

  1. Check your medication packaging for Methylprednisolone Tablets USP 4 mg, 21-count blister cards, with NDC 69306-004-21.
  2. Verify if your product matches the affected lot numbers: Lot 20K0043P (Expiration 8/31/2022) or Lot 20L0026P (Expiration 9/30/2022).
  3. Examine the printed dosing instructions on the blister card to see if they are misaligned or illegible.
  4. Contact your healthcare provider or pharmacist immediately for guidance if you have an affected pack, and do not change your dose without professional medical advice.
  5. Return any unused product to your pharmacy for a refund and contact Enovachem Pharmaceuticals at 310-320-0100 for further instructions regarding this recall.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider or pharmacist; return to pharmacy.

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

Affected Products

Product: Methylprednisolone Tablets, USP 4 mg, 21 Count Blister
Model:
NDC: 69306-004-21
Source NDC: 59746-001-03
Lot Numbers:
20K0043P (Exp. 8/31/2022)
20L0026P (Exp. 9/30/2022)
Date Ranges: Exp. 8/31/2022, Exp. 9/30/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87548
Status: Active
Manufacturer: Asclemed USA Inc. dba Enovachem Pharmaceuticals
Sold By: DocRx; Physician offices
Manufactured In: United States
Distributed To: California, Louisiana, Alabama
Agency Last Updated: April 13, 2021

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.