Recall report: Missing label, microbial contamination leads to recall of two batches of two drugs
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 firstname.lastname@example.org.
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.