My­lan Phar­ma­ceu­ti­cals has re­called a batch of Sem­glee in­sulin pens af­ter they were re­leased with­out la­bels, the FDA said.

A sin­gle batch of non-in­ter­change­able in­jec­tion, 100 units/ml, 3mL pack­aged in car­tons of five pens has been re­called. The batch — num­ber BF20003118 — ex­pires Aug. 2022.

The batch was made by Bio­con and dis­trib­uted by My­lan. A miss­ing la­bel could lead to a mixed-up dosage, and a pa­tient re­ceiv­ing treat­ment of more than one type of in­sulin, such as long- and short-act­ing in­sulin. That could lead to blood sug­ar lev­els too low or too high, and se­ri­ous com­pli­ca­tions.

No side ef­fects have been made pub­lic so far. The re­call doesn’t in­clude the re­cent­ly ap­proved in­ter­change­able ver­sion of Sem­glee, or the un­brand­ed gener­ic ver­sion. Cus­tomers with ques­tions sur­round­ing the re­call can con­tact Vi­a­tris cus­tomer re­la­tions by 800-796-9526 or cus­tomer.ser­vice@vi­a­tris.com.

Whole­salers are asked to ex­am­ine in­ven­to­ry and quar­an­tine and dis­con­tin­ue any dis­tri­b­u­tion of the lot.

My­lan and Pfiz­er’s Up­john unit merged in 2020, tout­ing a $12 bil­lion deal.

Worces­ter, MA com­pa­ny Lo­hxa al­so re­called a lot of its Sen­na Syrup, 8.8mg/5mL unit-dose cups to the con­sumers due to po­ten­tial mi­cro­bial con­t­a­m­i­na­tion. The nat­ur­al veg­etable lax­a­tive is used as re­lief for con­sti­pa­tion, and pack­aged in­to 5 mL cups and dis­trib­uted in cas­es of 20 car­tons. The af­fect­ed lot has an ex­pi­ra­tion date of Jan. 2023.

The use of a con­t­a­m­i­nat­ed prod­uct by the el­der­ly, pa­tients with weak­ened im­mune sys­tems or at high-risk for heart in­flam­ma­tion could re­sult in a life-threat­en­ing in­fec­tion. So far though, there have not been any re­ports of side ef­fects.

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

A Chinese pharma company is growing its presence in the US with a newly acquired API manufacturing site.

Pharmaron has entered into a definitive agreement to acquire a Coventry, Rhode Island-based API manufacturing site from drug manufacturer Noramco, which was previously owned by Johnson & Johnson and now owned by the private equity firm SK Capital.

According to Pharmaron, the site has an established history of API manufacturing from pilot kilogram to commercial metric ton scales. However, according to The People’s Radio, an NPR station covering Rhode Island and parts of Massachusetts, the facility was formerly owned by a subsidiary of Purdue Pharmaceuticals called Rhodes Technologies and was known for making opioid products. According to that report, because of Purdue’s 2019 bankruptcy filing, the Coventry factory was sold to Noramco, another opioid ingredient manufacturer.

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.