Burger line Burger line Burger line
Logo Logo Logo
Burger line Burger line Burger line
Sign in
Sign in

Labeling error forces Teva to recall 13 lots of fentanyl buccal tablets

Labeling error forces Teva to recall 13 lots of fentanyl buccal tablets
A labeling problem has forced Teva to recall 13 lots of fentanyl buccal tablets. Safety updates on the product insert were omitted, leaving the possibility of misuse that “could lead to life-threatening adverse events,” the FDA said.

The likelihood harm stemming from the error is “remote,” according to a hazard assessment conducted by Teva. The company has not yet received any complaints related to the product’s labeling, it said.

Teva manufactured and labeled the product for Mayne Pharma. The recall is to the consumer level.

The 13 lots are for a variety of strengths of the product, ranging from 100 to 800 microgram doses. Expiration dates of the lots range from June of 2023 to November of 2024. The tablets come in packages of 28, with four cards containing seven pills each.

Fentanyl buccal is an opioid agonist, indicated for the management of breakthrough pain in adult cancer patients who are already receiving and are tolerant to around-the-clock opioid therapy.

The recall comes after a major transition for Mayne Pharma. In December, the company paid $153 million to license women’s healthcare products from TherapeuticsMD, which made the move after failing to sell itself.

Then two months later, Mayne sold a chunk of its U.S. generics portfolio to Dr. Reddy’s Laboratories of India. That deal was for up to $105 million and included four pipeline and 40 approved but unmarketed drugs.

May 1, 2023

0
Cart Subtotal:
Go to cart
You will be able to Pay Online or Request a Quote

We use "cookies*  to ensure the functionality of our website, recognise your browser or device, learn more about your interests, and provide you with essential features and services and for additional purposes, including:

Recognising you when you sign-in to use our services. This allows us to provide you with product recommendations, display personalised content, and provide other customised features and services.
Keeping track of your specified preferences. You may set your preferences through Your Account..
Keeping track of items stored in your shopping basket and personal cabinet.
Conducting research and diagnostics to improve ChemDiv’s content, products, and services.
Delivering content, including ads, relevant to your interests on ChemDiv’s site
Reporting. This allows us to measure and analyse the performance of our services.

By  cookies you give consent to the processing of your personal data, including transfer to third parties. Further information can be found in our privacy policy.

Accept all cookies