Mylan Institutional recalls lot AJ21002 of octreotide acetate injection, 500 mcg/mL, packaged in a carton of 10 1mL syringes due to report of glass particles in syringe; lot was distributed in US between January 11 to June 21, 2022

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PITTSBURGH , October 20, 2022 (press release) –

Mylan Institutional LLC, a Viatris company, is voluntarily recalling one lot of its Octreotide Acetate Injection, 500 mcg/mL, packaged in a carton of ten 1mL syringes. This lot is being recalled at the retail level (hospital pharmacy) due to a product complaint of the presence of glass particles in a syringe.

This lot was manufactured by Italfarmaco SpA, Italy and was distributed by Mylan Institutional LLC in the US between January 11 and June 21, 2022. The recalled lot is as follows:

NDC #

Name and Strength

Size

Lot#

Expiry

67457-246-00(Syringe)

67457-246-01 (Carton)

Octreotide Acetate Injection
500 mcg/mL

10 X 1 mL Single dose
unit-of-use Syringe

AJ21002

March 2024

 

Risk Statement: Intravenous administration of a solution containing particulate matter, such as a glass, could lead to events including, but not limited to, local irritation or swelling, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism. Although the intravenous administration of a solution containing particulate matter may pose potential risk of serious adverse events, the probability of exposure from this incident and subsequent risk is low. To date, no reports of adverse reactions associated with this lot have been received.

Octreotide Acetate Injection is indicated to reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. It is also indicated for the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease and for the treatment of the profuse watery diarrhea associated with vasoactive intestinal peptide (VIP)-secreting tumors.

Action: The company has initiated the recall of lot AJ21002 and notified its distributors by letter/phone and is arranging for retuof all recalled products. Following are actions for wholesalers and retailers (hospital pharmacies):

Wholesalers: Immediately examine your inventory, quarantine and discontinue distribution of this lot. In addition, if you have further distributed the product, please identify your retail level customers and provide a list of customers via Microsoft excel file to mylan8281@sedgwick.com within 5 business days. Sedgwick will notify your retail level customers that received the affected batches.
Retailers (Hospital Pharmacies): Immediately examine your inventory, quarantine and discontinue distribution of this lot.
Wholesalers and retailers please proceed to items listed below:

  • Immediately examine your inventory, quarantine, and discontinue distribution of this lot.
  • Carry out a physical count and record this data on the Business Reply Card and Packing Slip which are included.
  • Mail the postage paid Business Reply Card to the address provided.
  • Retuthe recalled product with the Packing Slip using the prepaid UPS RetuService shipping labels to:

Sedgwick
Event # 8281
2670 Executive Drive, Suite A
Indianapolis, IN 46241
(888) 266-7974

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and retuto the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Viatris
Viatris Inc. (NASDAQ: VTRS) is a global pharmaceutical company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020, Viatris brings together scientific, manufacturing and distribution expertise with proven regulatory, medical, and commercial capabilities to deliver high-quality medicines to patients in more than 165 countries and territories. Viatris' portfolio comprises more than 1,400 approved molecules across a wide range of therapeutic areas, spanning both non-communicable and infectious diseases, including globally recognized brands, complex generic and branded medicines, a portfolio of biosimilars and a variety of over-the-counter consumer products. With approximately 37,000 colleagues globally, Viatris is headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Leamore at viatris.com and investor.viatris.com, and connect with us on Twitter at @ViatrisInc, LinkedIn and YouTube.

Contacts:

Media:
+1.724.514.1968
Communications@viatris.com
Kimberly Wise
Kimberly.Wise@viatris.com

Investors:

+1.724.514.1813
InvestorRelations@viatris.com
Bill Szablewski
William.Szablewski@viatris.com

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Viatris Inc. published this content on 18 October 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 18 October 2022 23:57:14 UTC.

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