Elevated risk U.S. Food and Drug Administration

Mylan Institutional Octreotide Acetate Injection, 500 mcg/mL recall: Due to glass particulates

Recall published 4+ years ago

Due to glass particulates

The hazard: Lead or heavy metal content

Lead is the reason for this notice. The important thing is removing the source and asking about a blood test, in that order.

What the notice says: 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.

Why it matters: The product exceeds the federal limit on lead or another heavy metal. Lead harms the developing brain, and the damage builds quietly from small repeated exposures rather than arriving as a single dramatic poisoning.

Symptoms and when to call a doctor

The CDC states there is no known safe level of lead in a child’s blood, and that most children with elevated levels show no symptoms at all. That is why a blood lead test, not a symptom check, is the way to find out. Ask your paediatrician about testing if a child has handled, mouthed or worn the product regularly. Where symptoms do appear they are non-specific — irritability, poor appetite, stomach pain, tiredness, constipation or a drop in attention and learning.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
October 25, 2022
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Mylan Institutional
Product type
Prescription & OTC drugs
Reports of harm
To date, no reports of adverse reactions associated with this lot have been received.

Products covered by this recall

Octreotide Acetate Injection, 500 mcg/mL

What the company announced

FOR IMMEDIATE RELEASE – PITTSBURGH, October 25, 2022- Mylan Institutional LLC, a Viatris company, is voluntarily recalling lot AJ21002, exp 3/2024, of Octreotide Acetate Injection, 500 mcg/mL, packaged in a carton of ten 1mL syringes. This lot is being recalled at the user (hospital/pharmacy) level 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 #: 67457-246-00 (Syringe) 67457-246-01 (Carton) · Name and Strength: Octreotide Acetate Injection 500 mcg/mL · Size: 10 X 1 mL Single dose unit-of-use Syringe · Lot#: AJ21002 · Expiry: 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 return of all recalled products. Following are actions for wholesalers and retailers/users (hospitals/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 [email protected] within 5 business days. Sedgwick will notify your retail level customers that received the affected batches.

Retailers/Users (Hospitals/Pharmacies): Immediately examine your inventory, quarantine and discontinue distribution of this lot.

Wholesalers and retailers (hospitals/pharmacies) 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.

Return the recalled product with the Packing Slip using the prepaid UPS Return Service 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 return to 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. Learn more at viatris.com and investor.viatris.com , and connect with us on Twitter at @ViatrisInc , LinkedIn and YouTube .

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 7 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • AJ21002
  • 500

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 3/2024
  • March 2024

NDC number

On the carton and again on the bottle or blister label.

  • 67457-246-00

Model or item number

On the rating label, the box or the instruction sheet.

  • 000

Package size

Match the net weight or the piece count on the front of the pack.

  • 1 mL

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Lead

Mylan Institutional — Lead is the reason for this notice. The important thing is removing the source and asking about a blood test, in that order.

  1. Take the product away from children and stop using it — do not keep it for decoration where a child can reach it.
  2. Follow the remedy on this page — lead recalls almost always carry a full refund.
  3. Wash the hands of anyone who has been handling it, and wipe down the surfaces it has been sitting on.
  4. Ask your paediatrician whether a blood lead test is warranted, especially for a child under six or anyone pregnant.

How the remedy works

CPSC recalls specify one of three remedies, and which one you get is not negotiable — but how smoothly it goes often is.

  • A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.
  • Several recalls now ask you to destroy the item and send a photo as proof. Register the claim before you do that, never after.
  • Return shipping is the company’s cost. If you are asked to pay it, push back.
  • A repair kit is shipped free and is designed to be fitted at home; if you cannot fit it, ask whether they will arrange installation.

Company contact: Mylan Institutional LLC, a Viatris company — Consumers: Kimberly Wise, 724-514-1968, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Mylan Institutional prescription & otc drugs recalled?

Due to glass particulates 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code AJ21002, 500; best-by date 3/2024 or March 2024; model number 000. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Take the product away from children and stop using it — do not keep it for decoration where a child can reach it.

Can I get my money back?

A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.

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