Octreotide Acetate Injection, Solution
FDA Recall NDC 67457-239
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Octreotide Acetate (NDC 67457-239). A significant event, classified as Class I, was initiated on Oct 07, 2022 by Mylan Institutional Llc. The reported reason for this action was: "Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
Oct 07, 2022
Nov 16, 2022
22400 syringes
Recall Profile & Regulatory Data
Event ID
90974
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Viatris Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jan 12, 2024
Product Description
Octreotide 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).
Batch or Lot Expiration Information
Lot# : AJ21002, Exp. 03/2024
Affected Packages Involved in this Recall
67457-239-00Product
67457-239-01Product
67457-245-00Product
67457-245-01Product
67457-246-00Product
67457-246-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
