Akorn's Hi-Tech is the source of large Actavis recall

Akorn

The recalls for generic drugmaker Hi-Tech Pharmacal continue to pile up and this time it is bad news for another drugmaker.  The unit of Akorn ($AKRX) is recalling of hundreds of thousands of bottles of sterile ophthalmic solution, most of it produced for Allergan's Actavis.

According to the most recent FDA Enforcement Report, Actavis is voluntarily recalling 24 lots, amounting to 447,150 bottles, of ciprofloxacin ophthalmic solution that was manufactured by Hi-Tech. The solution failed impurities and degradation specs for an unknown impurity. Separately, Corona, CA-based Aidarex Pharmaceuticals is recalling 599 bottles of solution itself, which it got from Hi-Tech and then repackaged. The recalls began back in March but were only classified by the FDA in the last week.

These recalls surfaced after Hi-Tech also recalled 57,920 bottles of sulfacetamide sodium ophthalmic solution that failed antimicrobial effectiveness testing. In March it also began recalling 7,200 bottles of dental mouth rinse which the FDA says failed impurities testing. That added up to about 909 gallons of the rinse.

Conference

The 13th Annual Digital Pharma East

Digital Pharma East returns to the Pennsylvania Convention Center September 17–20, bringing together over 1000 attendees from biotech and pharma, to better understand how to present business plans, justify budget and innovation, and de-risk proposals getting shut down — essentially, understand how they can return to the office and become champions for their internal digital needs. Join us and save 15% on standard rates when you register with Discount Code DPE19Fierce.

Akorn bought Hi-Tech in 2013 for $640 million as part of a buildup by the Lake Forest, IL-based company. It has had any number of significant recalls when measured in units retrieved. Last year it recalled more than 355,000 bottles of its generic of Bactrim made for children after it was found to be out of specification for the dissolution of sulfamethoxazole, one of two active ingredients in the product. A couple of months later, it recalled hundreds of thousands of bottles of the generic anxiety drug hydroxyzine hydrochloride because it failed impurities specifications.

- access the recalls here

Related Articles:
Akorn and Hi-Tech recall more than 900 gallons of dental rinse
Akorn's Hi-Tech source of another recall 
Akorn antibiotic recall stems from its buyout of Hi-Tech 
Allergan’s Actavis recalls nearly 600,000 bottles of ADHD drug

Read more on

Suggested Articles

Novartis' AveXis will use Catalent for some manufacturing of its newly approved gene therapy Zolgensma and more manufacturing news of note.

Pharmacy chain Rite Aid has partnered with Google to have their drug recycling stations easily searchable on Google Maps. 

Precision BioSciences says it will have a manufacturing facility for its off-the-shelf CAR-T therapies up and running in the fourth quarter.