Recall of Dronabinol & Ziprasidone Hydrochloride - MedWaste Management Recall of Dronabinol & Ziprasidone Hydrochloride - MedWaste Management

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Recall of Dronabinol & Ziprasidone Hydrochloride

An immediate recall has been issued by The Harvard Drug Group after two of their medications, Dronabinol and Ziprasidone Hydrochloride were involved in a labeling mix-up. It was reported that a package of Dronabinol Capsules was incorrectly labeled as Ziprasidone Hydrochloride. At this time, only a single lot of each medication is being recalled, as it is thought that other lots have been labeled correctly.

At the time of the writing of this notice, no adverse events have been reported as a result of the mix-up.

SUMMARY

Date of Recall:

Announced: June 13, 2023

Public Notification: June 14, 2023

Name(s) of Drug:

Dronabinol Capsules, USP, 2.5mg

Ziprasidone Hydrochloride Capsules, 20mg

Company Name:

The Harvard Drug Group, LLC

d/b/a Major Pharmaceutical

d/b/a Rugby Laboratories

Drug Indication:

Dronabinol (nausea/vomiting during chemotherapy, treatment of weight loss, and lack of appetite in HIV patients)

Ziprasidone Hydrochloride (schizophrenia, bipolar disorder, other mood disorders)

Label for Ziprasidone Hydrochloride Under recall Label for Dronabinol under recall Label for Dronabinol under recall

Product Description

Dronabinol is a white capsule, imprinted with “M2.”

Ziprasidone Hydrochloride is a capsule with a lavender opaque end and a flesh opaque body. “RDY is printed on the lavender end and “356” is printed on the flesh end.

Reason for Recall

While no adverse events have yet been reported, the mislabeling of the medication can result in consumers receiving medications that they are not prescribed to take and missing doses of their necessary medications.

Impacts

Dronabinol is a man-made form of marijuana. While the side effects from taking it are typically mild, they can include dizziness, drowsiness, an exaggerated feeling of well-being, stomach pain, fainting, fast heartbeat (tachycardia), mood changes, hallucinations, and paranoia. For those who are prescribed the medication, symptoms such as nausea, lack of appetite, and vomiting may return when doses are missed. Furthermore, replacing this medication with Ziprasidone can result in further increased nausea and decreased appetite.

Ziprasidone is an antipsychotic and works by binding to serotonin and dopamine receptors in the brain, thus changing the balance of those chemicals. Its side effects include headache, restlessness, loss of appetite, constipation, diarrhea, cough, runny nose, weight gain, dizziness, stomach pain, and others. These side effects can be quite dangerous for patients who are not prescribed the medication. Furthermore, for patients who are on the medication, sudden discontinuation of their usual dose can result in dangerous withdrawal symptoms such as panic attacks, mood swings, hallucinations, anorexia, vomiting, insomnia, confusion, weakness, and suicidality.

Lot Information

Consumers who use the medications listed above should locate their medication’s package and compare the brand name, dosage, lot number, NDC, and expiration date.

Product Description

Package Description

Brand Name

Lot Number

NDC

Expiration Date

Dronabinol
Capsules, USP, 2.5 mg
100 Unit Doses per
Carton
(10 x 10 blister packs)
Major
T04769
0904-7144-61
2024/12
Ziprasidone
Hydrochloride
Capsules, 20 mg
40 Unit Doses per
Carton
(10 x 4 blister packs)
Major
T04769
0904-6269-08
2024/12

FDA.gov

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

Consumers

If you find that your lot of medication is part of this recall, do the following:

  1. Call your doctor right away. Ask for a new prescription to replace your recalled medication and report any symptoms that you’re experiencing.
  2. Continue to monitor your health for any adverse symptoms over the next week and notify your physician if any concerns are noted.
  3. Consumers may contact Sedgwick, Inc at 1-888-759-6904. They are available Mon-Fri from 9:00am to 5:00pm (EST). They are also available via email at harvarddrug6068@sedgwick.com.
  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/or assistance with disposing of the recalled medication.

Retailer

  1. Examine all inventory and remove stock that is affected by the recall immediately.
  2. Contact Sedgwick, Inc at 1-888-759-6904 or you can utilize harvarddrug6068@sedgwick.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/or assistance with disposing of the recalled medication.

Wholesaler

  1. Examine all inventory and remove stock that is affected by the recall immediately.
  2. Contact Sedgwick, Inc at 1-888-759-6904 or you can utilize harvarddrug6068@sedgwick.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/or assistance with disposing of the recalled medication.

 

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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!

 

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