Mylan Prescription drugs has issued a voluntary recall of 1 batch of its 100 models/mL insulin glargine injection pens as a result of potential for lacking labels, in response to a press launch from the FDA.
The recall impacts batch BF21002895 of Mylan’s unbranded insulin glargine-yfgn, a long-acting insulin analog indicated for bettering glycemic management for adults and youngsters with kind 1 diabetes and adults with kind 2 diabetes. Folks receiving remedy with a couple of kind of insulin might combine up insulin merchandise if there’s a lacking label on the pens. This might end in much less optimum glycemic management and critical issues.
The batch was manufactured by Biocon Sdn Bhd and was distributed by Mylan Prescription drugs within the U.S. between April 4, 2022, and Could 5, 2022. The product info, batch quantity and expiration date are current on the carton distributed to customers.
That is the second recall Mylan Prescription drugs has issued in lower than 3 months associated to its unbranded insulin glargine-yfgn. As Healio beforehand reported, the corporate recalled a batch of its 100 models/mL insulin glargine in April 2022 as a result of potential for a lacking label on some vials.
Mylan Prescription drugs has notified its distributors and retailers and is arranging for a return of all recalled merchandise. Sufferers who’ve an unlabeled pen ought to contact Sedgwick at 1-877-643-8438 to obtain a documentation packet to return the product.
No hostile occasions associated to this recall have been reported. Anybody wishing to report an hostile occasion or high quality issues with the product can achieve this by way of the FDA’s MedWatch Hostile Occasion Reporting program at www.fda/medwatch/report.htm.
Anybody with questions concerning the recall can contact Viatris buyer relations at 1-800-796-9526 or firstname.lastname@example.org, Monday via Friday from 8 a.m. to five p.m. Japanese. Sufferers ought to contact their well being care supplier with any drawback associated to take or utilizing the recalled product.
This recall is being performed with the information of the FDA.