FDA Recall of Injectable Medication - MedWaste Management FDA Recall of Injectable Medication - MedWaste Management

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Treprostinil FDA Recall Drug

FDA Recall of Injectable Medication

The FDA has released an immediate recall for Treprostinil Injection, a medication used in the treatment of PAH (Pulmonary Arterial Hypertension). The drug’s manufacturer, Par Pharmaceutical, Inc., based in Dublin, Ireland, has discovered that there is the potential for silicone particular matter within the solution. If this is the case, the particulates pose dangerous health risks for patients who receive the medication.

As of this notice, the FDA has not announced any reports of adverse events related to particulate matter.

SUMMARY

Date of Recall:

Announced: March 12, 2024

Public Notification: March 12, 2024

Name(s) of Drug:

Treprostinil 20mg/20mL Injection

Company Name:

Endo International, Par Pharmaceutical

Drug Indication:

PAH (Pulmonary Arterial Hypertension)

Treprostinil FDA Recall Drug

Product Description

Treprostinil is distributed to hospitals and doctor’s offices nationwide. The solution is contained in multidose vials and packaged in individual cartons that bear the drug name, strength, NDC, Lot number, and expiration date. Treprostinil is available by prescription only.

Reason for Recall

Par Pharmaceutical, the drug’s manufacturer, noted that silicone particulate may have entered the product solution during the creation and packaging of the product.

Impacts

Consumers who receive an intravenous injection of the solution are at serious risk of health outcomes related to the silicone particulate. The particles may travel throughout the bloodstream and block vessels to vital organs, leading to stroke or death.

Lot Information

Healthcare workers: Check your stock carefully to ensure that the recalled medication is removed and not administered to your patients. If you find that you have the recalled drug in stock, read below for instructions on disposal.

Consumers: If you believe you have been administered this medication, ask your healthcare provider to verify that you have not received a dose from the recalled stock. Communicate any health changes with your physician immediately.

Product Name
Strength
NDC #
Lot #
Exp. Date

Treprostinil Injection

20mg/20mL (1mg/ml) 42023-206-01 57014

04/2024

FDA.gov

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

Consumers

  1. Call your doctor right away. Report the use of the recalled medication.
  2. Monitor your health for any adverse symptoms and notify your physician if any concerns are noted.
  3. Consumers with questions may contact Inmar, Inc. by phone at 1-855-410-3565. They are available Monday through Friday from 9 a.m. to 5 p.m., EST.
  4. 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.
  5. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Medical Facilities

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact Inmar, Inc. by phone at 1-855-410-3565. Notify them of any recalled batches that have already been administered to patients.
  3. Notify affected patients of recalled batches that they have already received.
  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 Inmar, Inc. by phone at 1-855-410-3565. Notify them of any recalled batches that have already been shipped to medical facilities.
  3. Notify affected facilities 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 Healthcare Content Creator Byline Image

Tammy McKinney, RN, creator 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 reach out to her directly on LinkedIn!

One response

  1. Kathryne Beier Avatar

    This is so helpful, especially the tips you provided. Thanks a lot!


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