Mfg News: Teva, Viatris, USP & NIPTEBy
A roundup of manufacturing news from Teva, Viatris, USP and NIPTE.
Teva Recalls One Lot of Leukemia Drug
Teva Pharmaceuticals has initiated a voluntary nationwide recall of one lot of idarubicin hydrochloride injection, USP 5 mg/5 mL vial, to the user level in the US, based on an internal inspection that found particulate matter in one vial of the product identified as silica and iron oxide.
Teva reports that no other vials have been observed to contain this defect. To date (as reported on March 29, 2022), Teva says it has received no product-quality complaints or adverse-event reports for the subject recall lot.
The drug is used to treat acute myeloid leukemia in adults. It is packed in 5-mL single-dose vials. Teva distributed 1,565 vials nationwide from December 4, 2020 through August 18, 2021 to four of its wholesale customers under the label for Teva Pharmaceuticals USA, Inc.
Source: US Food and Drug Administration
Viatris Recalls One Batch of Insulin Glargine
Mylan Pharmaceuticals, a Viatris company, is voluntarily recalling one batch of insulin glargine (insulin glargine-yfgn) injection, 100 units/mL (U-100), due to the potential for the label to be missing on some vials.
The product is packaged in a 10-mL vial that is inside a carton. This product is not the branded Semglee vial but the unbranded insulin glargine-yfgn vial. The product information, batch number, and expiry date information are present on the carton.
The product is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus.
This batch was manufactured by Biocon Sdn. Bhd, the Malaysian subsidiary of Biocon Biologics, a developer of biosimilars and part of Biocon, a Bangalore, India-based bio/pharmaceutical company. The batch was distributed by Mylan Specialty L.P. in the US between December 9, 2021, and March 4, 2022.
USP, NIPTE Partner for Continuous Mfg Knowledge Center
The US Pharmacopeia (USP), a non-profit scientific and standards-setting organization, and the National Institute for Pharmaceutical Technology and Education (NIPTE), a non-profit academic organization that collaborates with industry, academia, and government, have initiated a joint effort to create the Knowledge Center for Pharmaceutical Continuous Manufacturing (PCM) technology.
The result will be a digital knowledge-management resource for capturing, contextualizing, organizing, and updating knowledge about PCM with the goal of facilitating innovation in PCM and lowering barriers to its adoption.
Funding support for the establishment of the knowledge-management system for PCM is provided by the US Food and Drug Administration (FDA) through a grant awarded to NIPTE. The Knowledge Center for PCM online platform is anticipated to be fully operational and publicly accessible later this year (2022).