Mylan Institutional LLC Recalls One Lot of Octreotide Acetate Injection, 500 mcg/mL Because the Syringe Contains Glass Particulates

Mylan Institutional LLC, a Viatris Company, has issued a voluntary recall of one lot of its Octreotide Acetate Injection AJ21002, exp 3/2024 due to the presence of glass particulates in the syringe.

The 500 mcg/mL strength is packed in a carton containing ten 1ml syringes and was distributed nationwide in the U.S. to wholesalers/distributors (including hospitals and clinics) from January 11 and June 21, 2022.

The affected lots are as follows:

Risk Statement

A solution containing glass particulates introduced during the manufacturing process could result in local irritation and inflammation upon injection. If glass particulates are injected into the bloodstream, they could potentially cause damage to blood vessels or embolization.

The administration of parenteral drug products containing particulates has been associated with localized tissue reactions and thromboembolic events.

However, the probability of exposure and risk is relatively low. To date, Mylan Institutional LLC has not received any reports of adverse events associated with this issue.

Octreotide Acetate Injection is a medication used to treat certain hormone problems and other conditions. It is also used as a diagnostic tool in certain imaging procedures. Octreotide belongs to a class of drugs known as somatostatin analogs.

Octreotide works by mimicking the effects of a natural hormone called somatostatin. Somatostatin regulates the release of other hormones in the body, including growth hormones and insulin. Octreotide helps to decrease the levels of these hormones when they are too high.

The medication is used to treat patients with Acromegaly (a condition caused by too much growth hormone) who have an inadequate response or cannot be treated by pituitary irradiation, surgical resection, and bromocriptine mesylate at maximally tolerated doses.

It’s also used to treat patients with Carcinoid tumors (a type of tumor that can occur in various parts of the body, including the gastrointestinal tract and lungs) who cannot be treated by surgical resection.

The medication suppresses or inhibits the secretion of certain hormones, including gastrin, insulin, glucagon, and somatostatin.

Octreotide is also used to treat Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D). This condition is characterized by abdominal pain and cramping, bloating, gas, diarrhea, and constipation.

Octreotide works by decreasing the secretion of certain fluids in the gastrointestinal tract, which helps to relieve these symptoms.

Actions to Take

Mylan Institutional LLC recalls lot AJ21002 by sending notifications to its customers by letter/phone and is preparing to receive the returned products.

Wholesalers are urged to check their inventory and quarantine, and discontinue the sale of the affected lot. They should also identify their retail-level customers and provide a Microsoft Excel file to [email protected]. Sedgwick will take care of notifying the customers of the recall of the affected products.

Retailers/Users (Hospitals/Pharmacies) should also check their inventory if they have the affected lot, quarantine, and discontinue the distribution of the affected lot.

Wholesalers and retailers of the affected products are also required to take the following actions:

• Quarantine and discontinue the distribution of the affected products
• Carry out a physical count and record the data to the Business Reply Card and Packing Slip
• Mail the postage-paid Business Reply Card
• Return the recalled product with the Packing Slip and using the prepaid UPS Return Service shipping labels to the following addresses:

Sedgwick

Event # 8281

2670 Executive Drive, Suite A

Indianapolis, IN 46241

(888) 266-7974

Any reports on adverse reactions or quality issues should be reported to FDA’s MedWatch online, through fax, or by regular mail.

• 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

The recall is made with the knowledge of the U.S. Food and Drug Administration.