Allergan’s Actavis recalls nearly 600,000 bottles of ADHD drug

Actavis facility in Iceland
Actavis facility in Iceland

Teva ($TEVA) is expecting to close on its buyout of Allergan’s generic drug business, but for now Actavis is still Allergan’s, for better or worse. That means that Allergan ($AGN) is responsible for the recall of more than 50 lots, consisting of nearly 600,000 bottles, of its copy of the ADHD drug Adderall.

According to the most recent FDA Enforcement Report, Actavis is voluntarily recalling 54 lots involving four different dose forms of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets after they failed tests for impurity levels. The recall was initiated in February but was just classified by the FDA last week as a Class II recall. The nationwide includes 38,507 bottles of 5 mg tablets, 114,388 bottles of 10 mg tablets, 257,746 bottles 20 mg tablets and 182,378 bottles of 30 mg tablets.

The manufacturing mess-up comes as Allergan and Teva are awaiting regulatory approval of their $40.5 billion deal. The two had hoped to close the deal at the end of March, but a couple of weeks ago, Teva said the U.S. Federal Trade Commission said it needed more time to evaluate the massive deal. Now the Israeli drugmaker said the closing might be put off until June.

Cambrex Webinar

Understanding the Importance of Crystallization Processes to Avoid Unnecessary Cost, Risk and Development Delays

Wednesday, May 27, 2020 | 10am ET / 7am PT

A well-developed crystallization process can produce suitable particles that can facilitate consistent filtration, drying and formulation of the API and allow confident and reliable manufacturing of the final drug product, while avoiding unnecessary cost, risk and development delays.

The European Union signed off on the transaction last month, but with caveats. Teva has to sell off some business to even out the playing field, regulators said. The company agreed to sell "a majority" of Allergan's current generics business in the U.K. and Ireland and agreed to jettison molecules in 24 other countries in Europe. In Iceland, where Actavis originated, Teva will discard its own business while hanging onto the Dublin drugmaker's.

- access the recall notices here

Read more on

Suggested Articles

The eight-year deal will initially cover lupus drug Benlysta and could expand to other GSK specialty-care products in the future.

With a new £131 million contribution from the U.K. government, VMIC aims to both speed up and expand on its prior ambitions.

Pricing controversies shouldn't overshadow Phlow's promise to provide low-cost drugs to address COVID-19, says the CEO of partner Civica Rx.