Recall, warning, and a new generic drug
Insulin cartridge holders were recalled, patients were warned about pre-owned test strips, and a generic form of rosiglitazone maleate and metformin hydrochloride was approved.
Certain batches of NovoPen Echo insulin cartridge holders are being recalled by the manufacturer because they may crack or break if exposed to certain chemicals, such as cleaning agents, the FDA announced on July 5.
Related adverse events and other complaints have been reported, and affected products were distributed between Aug. 1, 2016, and June 22, 2017. The manufacturer has corrected the problem and is providing replacement cartridge holders for consumers whose devices were affected by the recall, according to the announcement.
The FDA also announced on May 19 that it approved the generic form of rosiglitazone maleate and metformin hydrochloride tablets (1 mg [base]/500 mg) to improve glycemic control in adults with type 2 diabetes as an adjunct to diet and exercise. The combination drug had previously been sold under the brand name Avandamet.
Finally, the agency warned consumers on May 16 that it does not recommend buying unused, pre-owned test strips. Although it is technically legal for people to resell their test strips, the FDA warned that pre-owned strips may give inaccurate results and may not be safe to use with all glucose meters.