Recall of Potentially Deadly Fentanyl Tablets - MedWaste Management Recall of Potentially Deadly Fentanyl Tablets - MedWaste Management

Medical Waste and the Healthcare Industry Blog

Stay tuned to our blog for timely updates and insights into the ever-evolving landscape of medical waste news and developments.

Recall of Potentially Deadly Fentanyl Tablets

Teva Pharmaceuticals USA has issued an immediate recall of certain lots of Fentanyl Buccal (placed in cheek) Tablets CII due to missing information in the product insert. Lack of proper safety information within the insert can lead to serious health ramifications due to mis-use by consumers. As of the writing of this notice, no adverse events have yet been reported.

SUMMARY

Date of Recall:

Announced: April 27, 2023

Public Notification: April 28, 2023

Name(s) of Drug:

Fentanyl Buccal Tablets CII

Company Name:

Mayne Pharma, Inc. (brand)

Teva Pharmaceuticals USA (manufacturer)

Drug Indication:

Pain

Product Description

Product is packaged in white boxes with a single orange, green, blue, pink or yellow stripe. The box contains 7 cards, each containing 4 tablets. Each tablet within the card is encased in a foil lined, childproof blister. Each tablet is a flat, white, round tablet debossed with a “C” on one side and a 1, 2, 4, 6 or 8 on the other.

Reason for Recall

Updates made to the products insert and medication guide were omitted and potentially leave room for the consumer to receive mis-information that can lead to improper use of this potentially dangerous medication.

Impacts

Consumers who receive mis-information could potentially receive an incorrect dose of the medication. Receiving less than prescribed doses of the medication could lead to continued symptoms or symptoms of withdrawal (see below). For consumers receiving more than the prescribed dose, symptoms could include:

  • Pinpoint Pupils
  • Slurred Speech
  • Inability to Walk Properly
  • Falling Asleep
  • Loss of Consciousness
  • Cold, Clammy Skin
  • Slowed Breathing
  • Complete Lack of Breathing
  • Death

Lot information

Consumers should locate the box in which the medication comes to compare NDC and lot numbers as well as expiration dates, strength, and size with the chart below. If you find your NDC number, lot number, strength, size and expiration date on the chart below, your medication is affected by the recall and you will need to take additional steps in order to ensure that your health is not affected and to take part in recall procedures.

NDC#
Lot
Exp. Date
Strength
Size
51862-634-28
42617828
06/2023
100 mcg
28 Buccal Tablets (4 Tablets x 7 Cards)
(4 tablets x 7 cards)
51862-634-28
100020465
01/2024
100 mcg
28 Buccal Tablets (4 Tablets x 7 Cards)
(4 tablets x 7 cards)
51862-635-28
100020528
09/2024
200 mcg
28 Buccal Tablets (4 Tablets x 7 Cards)
(4 tablets x 7 cards)
51862-635-28
100026699
11/2024
200 mcg
28 Buccal Tablets (4 Tablets x 7 Cards)
(4 tablets x 7 cards)
51862-636-28
100020351
11/2024
400 mcg
28 Buccal Tablets (4 Tablets x 7 Cards)
(4 tablets x 7 cards)
51862-636-28
100020522
09/2024
400 mcg
28 Buccal Tablets (4 Tablets x 7 Cards)
(4 tablets x 7 cards)
51862-636-28
100026700
11/2024
400 mcg
28 Buccal Tablets (4 Tablets x 7 Cards)
(4 tablets x 7 cards)
51862-637-28
42617831
06/2023
600 mcg
28 Buccal Tablets (4 Tablets x 7 Cards)
(4 tablets x 7 cards)
51862-637-28
42619585
11/2023
600 mcg
28 Buccal Tablets (4 Tablets x 7 Cards)
(4 tablets x 7 cards)
51862-637-28
100029649
11/2024
600 mcg
28 Buccal Tablets (4 Tablets x 7 Cards)
(4 tablets x 7 cards)
51862-638-28
42617832
06/2023
800 mcg
28 Buccal Tablets (4 Tablets x 7 Cards)
(4 tablets x 7 cards)
51862-638-28
42619530
08/2023
800 mcg
28 Buccal Tablets (4 Tablets x 7 Cards)
(4 tablets x 7 cards)
51862-638-28
100020532
11/2024
800 mcg
28 Buccal Tablets (4 Tablets x 7 Cards)
(4 tablets x 7 cards)

FDA.gov

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

Consumers

NOTE: CONSUMERS SHOULD NOT DISCONTINUE THIS MEDICATION ABRUPTLY. SPEAK TO YOUR DOCTOR BEFORE MAKING ANY CHANGES.

Discontinuation of this medication may cause return of pain symptoms or symptoms of Fentanyl withdrawal. These may include:

  • Diarrhea
  • Sweating
  • Insomnia
  • Dilated Pupils
  • Nausea
  • Sweating
  • Fever
  • Intense Cravings for Fentanyl

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 changes in your symptoms.
  2. Notify your physician of any change in your health.
  3. Once you have obtained a replacement for your medication, Teva is asking that you return any unused portion of the medication. Consumers should contact Teva at 1-855-246-5024 or via email at rxrecalls@inmar.com for assistance with returns.
  4. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately. Once you have sought medical assistance, please notify the pharmaceutical company at 1-888-483-8279 or contact them via email at USMedInfo@tevapharm.com. You may also 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 IBSA Pharma Inc at 1-855-246-5024 or via email at rxrecalls@inmar.com. 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 IBSA Pharma Inc at 1-855-246-5024 or via email at rxrecalls@inmar.com. 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.

We are MedWaste Management – California’s medical waste disposal experts!

Established in 2008, MedWaste Management fills a need for compliant and safe medical waste disposal to the healthcare industry and the general public alike. We publish this blog in order to spread useful and practical information to help you stay safe, smart and healthy!

Call us with any questions or to start service at (866) 254-5105. We are always happy to help!

Check out our services and other great resources in the links below.

Medical Waste Disposal Services

MedWaste’s Blog Index

Medical Waste Regulations

MedWaste’s Product Store

Learn How To Properly Manage & Dispose of Household Medical Waste

 

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!

I know I can count on you all to collect everything and do it safely.

You are a great company to work with. At our pharmaceutical production laboratory. We have gallons of leftover pharmaceutical waste that are a headache for our techs to deal with. I know I can count on you all to collect everything and do it safely. I’m pleased with the personal service.

M

Mitchell Adam

Got questions? Need our services?

We’ll get back to you by tomorrow — latest!

Fill the form