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Class I · Most seriousRecall completed

Octreotide Acetate

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot #: AJ21002, Exp. 03/2024
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in Italy foreign manufacturer
Brand nameOCTREOTIDE ACETATE
Generic nameOCTREOTIDE ACETATE
Active ingredient(s)OCTREOTIDE ACETATE
Distributed by / forMylan Institutional LLC, Morgantown, WV 26505 U.S.A., Made in Italy
NDC67457-246-00
Show the full FDA record
Full product labelOctreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or Intravenous Use, Rx Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., Made in Italy, NDC: 67457-246-00 (syringe), 67457-246-01 (carton).
Recalling firmViatris Inc
DistributionNationwide in the USA
Quantity22400 syringes
Recall initiated2022-10-07
Report date2022-11-16
Recall completed2024-01-12
Recall numberD-0058-2023
ClassificationClass I
FDA statusTerminated
Origin on fileCanonsburg PA United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.