Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or Intravenous Use
Summary
The FDA issued a Class I for Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syrin by Viatris Inc. Reason: Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe..
Details
Source
Drug Recall
External ID
D-0058-2023
Action Date
2022-11-16
Status
Terminated
Category
drug
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).
Lot/Code Info: Lot #: AJ21002, Exp. 03/2024
Quantity Affected: 22400 syringes
Reason for Recall
Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-07
Company
Canonsburg, PA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 45 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Viatris Inc has 23 FDA actions in our database, including 23 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Viatris Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Viatris Inc have FDA actions?
Viatris Inc has 23 FDA actions in our database, including 23 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0058-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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