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


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.

Free Webinar

Striving for Zero in Quality & Manufacturing

Pharmaceutical and medical device manufacturers strive towards a culture of zero – zero hazards, zero defects, and zero waste. This webinar will discuss the role that content management plays in pharmaceutical manufacturing to help companies reach the goal of zero in Quality and Manufacturing.

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


Suggested Articles

The FDA has slapped the parent of Dollar Tree stores with a warning letter saying some CMOs that made its OTC products were among the world's worst.

GSK expects Shingrix supplies to rise slightly in 2020, but the real "step change" will come in 2024 with a brand-new manufacturing facility.

Continuing its expansion efforts, Japan’s Fujifilm will make a major investment in its U.S. gene therapy operation in Texas.