---
title: "Mylan Institutional LLC: Octreotide Acetate Injection, 500 mcg/mL — FDA announcement Oct 25, 2022 | Is It on Recall"
description: "Due to glass particulates"
url: https://isitonrecall.com/recall/fdapress-d0e675e955473ee8-mylan-institutional-llc-octreotide-acetate-injection-500-mcg-ml/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA company announcement

# Mylan Institutional LLC: Octreotide Acetate Injection, 500 mcg/mL — FDA announcement Oct 25, 2022

Reported terminated

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Oct 25, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Octreotide Acetate Injection, 500 mcg/mL
- **Reason**: Due to glass particulates
- **Classification**: Not supplied
- **Recalling firm**: Mylan Institutional LLC, a Viatris company
- **Quantity**: Not supplied
- **Agency-reported status**: Terminated in FDA listing
- **Source record identifier**: d0e675e955473ee8

[Open the official record](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-institutional-llc-viatris-company-issues-voluntary-recall-one-lot-octreotide-acetate-injection)

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | 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:; 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.; 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 mylan8281@sedgwick.com 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.; Immediately examine your inventory, quarantine, and discontinue distribution of this lot.; 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 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

**FDA company announcement, table 1**

| 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 |

Announcement retrieved Oct 1, 2026. [Official announcement](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-institutional-llc-viatris-company-issues-voluntary-recall-one-lot-octreotide-acetate-injection).

## Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Fda listing date**: Oct 25, 2022
- **Company announcement date**: Oct 25, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-institutional-llc-viatris-company-issues-voluntary-recall-one-lot-octreotide-acetate-injection)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [Mylan Institutional LLC, a Viatris company records](https://isitonrecall.com/brand/mylan-institutional-llc-a-viatris-company/)