Mylan Voluntarily Recalls Additional Batch of Biosimilar Insulin Glargine Pens Due to Potential Missing Labels

Goodwin
Contact

Goodwin

On July 5, Mylan announced another voluntary recall of a batch of Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens “due to the potential for the label to be missing on some pens.”  The recalled product is not the branded SEMGLEE® pen, but rather the unbranded interchangeable Insulin Glargine-yfgn pens.  Mylan reports that no adverse events related to the recall have been recorded, and the recall was initiated due to the risk that patients receiving treatment with more than one type of insulin may mix up the products which could lead to complications.  The recalled batch was manufactured by Biocon Sdn. Bhd. and was distributed by Mylan Specialty L.P. in the United States.

This is Mylan’s third voluntary recall of insulin glargine this year, caused by the potential for the labels to be missing on some prefilled pens.  On January 18, Mylan recalled a batch of its non-interchangeable SEMGLEE® (insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens.  On April 12, Mylan recalled one batch of its unbranded Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100).

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Goodwin | Attorney Advertising

Written by:

Goodwin
Contact
more
less

Goodwin on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide