Second Recall Issued for Post-Transplant Immunosuppressive Agent - MedWaste Management Second Recall Issued for Post-Transplant Immunosuppressive Agent - MedWaste Management

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Sandimmune Cyclosporine Recall Again

Second Recall Issued for Post-Transplant Immunosuppressive Agent

The FDA has issued ANOTHER immediate recall for Sandimmune Oral Solution (Cyclosporine Oral Solution, USP) 100mg/mL. In September of 2023, we reported on a similar recall due to the formation of crystals in the drug that could result in incorrect dosing. This recall, initiated with the cooperation of Novartis Pharmaceuticals, is also due to crystal formation and can lead to incorrect dosage when taken orally. This puts organ transplant patients at high risk for rejection.

As of the writing of this notice, the FDA has not reported any adverse events related to the crystallization.

SUMMARY

Date of Recall:

Announced: November 24, 2023

Public Notification: November 27, 2023

Name(s) of Drug:

Sandimmune Oral Solution, 100 mg/mL

Cyclosporine Oral Solution, USP, 100 mg/ml

Company Name:

Novartis Pharmaceuticals Corporation

Drug Indication:

Organ Rejection

Rheumatoid Arthritis

Psoriasis

Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig Disease)

Product Description

Sandimmune oral is distributed in 50 mL bottles packaged in white boxes with blue trim. Each is clearly labeled with the drug name, strength, and lot information. The drug was distributed by pharmacies nationwide between January and September of 2022.

Reason for Recall

The drug is found to crystallize, leading to a solution that is non-uniform in its distribution. Therefore, ingestion of the crystals leads to higher dosing of the drug, while ingestion of the non-crystallized solution leads to ingestion of too-little dosages of the drug. There is no safe way to dose the medication once it has crystallized.

Impacts

Consumers who ingest the crystals will receive higher doses of the drug than intended. This can lead to Cyclosporine toxicity. Symptoms include:

  • Vomiting
  • Tiredness
  • Tachycardia (rapid heart rate)
  • Jaundice (yellowing of skin and whites of eyes)
  • Liver Damage
  • Kidney Damage
  • Swelling

Consumers who consume the non-crystallized solution after crystals have settled will receive a lower dose of the medication than indicated. This can lead to:

  • Rejection of a transplanted organ
  • Return of symptoms of psoriasis, rheumatoid arthritis, or ALS

Lot Information

Consumers who use Sandimmune Oral Solution, 100 mg/mL, should locate their medication and compare the lot number and expiration date to those below. See below for further instructions if your lot number and expiration date match.

Product Description
Lot Number
Expiration Date
Sandimmune Oral Solution (Cyclosporine, USP) 100 mg/mL FX001500 09/2024
Sandimmune Oral Solution (Cyclosporine, USP) 100 mg/mL FX001582 09/2024

FDA.gov

Have you found that your medication is part of the recall? Here’s what you should do:

Consumers

  1. If you believe you have ingested too high of a dose of the medication, call 911 immediately.
  2. Call your doctor right away. Ask for a new prescription to replace your recalled medication and report any changes in your symptoms.
  3. Continue to monitor your health for any adverse symptoms and notify your physician if any concerns are noted.
  4. Consumers who experience an adverse event should contact Novartis Consumer Interaction Center at 1-888-NOW-NOVA. They are available Mon-Fri from 8:30 a.m. to 5:00 p.m. (EST). You can also contact them via email at medinfo@ibsapharma.com.
  5. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
  6. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Retailer

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact Novartis at 1-888-669-6682, or you can utilize usdrugsafety.operations@novartis.com to contact them via email. Notify them of any recalled batches that have already been sold to consumers.
  3. Notify affected consumers of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact Novartis at 1-888-669-6682, or you can utilize usdrugsafety.operations@novartis.com to contact them via email. Notify them of any recalled batches that have already been shipped to retailers.
  3. Notify affected retailers of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

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Tammy McKinney, Nurse Writer

Tammy McKinney, RN, founder of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!


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