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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Octreotide Acetate Injection Recalled for Glass Particles

Agency Publication Date: November 8, 2022
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Summary

Viatris Inc is recalling approximately 22,400 syringes of Octreotide Acetate Injection (500 mcg/mL) due to a report of glass particles being found inside a syringe. This prescription medication is a single-dose injectable used for treating certain hormonal and digestive conditions. To date, no injuries or adverse events have been reported in connection with this recall.

Risk

Injecting a solution containing glass particles can cause localized irritation, swelling, or inflammation at the injection site. If the particles enter the bloodstream, they could potentially travel to and damage vital organs like the heart, lungs, or brain, which may result in serious health complications or life-threatening injuries.

What You Should Do

  1. This recall affects Octreotide Acetate Injection (500 mcg/mL) sold in cartons containing ten 1 mL single-dose unit-of-use syringes.
  2. Check your supply for affected product identifiers including lot number AJ21002 with an expiration date of 03/2024, and NDC numbers 67457-246-00 (located on the syringe) or 67457-246-01 (located on the carton).
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange for the return of any remaining units.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Octreotide Acetate Injection (500 mcg/mL)
Variants: 500 mcg/mL, 1 mL Single-Dose Unit-of-Use Syringes, Rx Only
Lot Numbers:
AJ21002 (Exp. 03/2024)
NDC:
67457-246-00
67457-246-01

Manufactured for Mylan Institutional LLC; 10 x 1 mL syringes per carton.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90974
Status: Resolved
Manufacturer: Viatris Inc
Sold By: Mylan Institutional LLC
Manufactured In: Italy, United States
Units Affected: 22400 syringes
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท FDA Press Release ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.