Octreotide Acetate Injection Recalled for Glass Particle Contamination
Viatris Inc is recalling Octreotide Acetate Injection due to glass particles found in syringes. Approximately 22,400 syringes of lot #AJ21002 (expiration 03/2024) were distributed nationwide.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall, the highest classification for drug recalls. FDA Class I is explicitly listed in the Score 5 (Critical) criteria. Glass particle contamination in an injectable drug poses a direct hazard of injection site injury or internal harm if administered.
Plain-English summary
Viatris Inc is recalling Octreotide Acetate Injection 500 mcg/mL in single-dose unit-of-use syringes due to the presence of glass particles in a syringe. The affected lot is #AJ21002 with an expiration date of March 2024. Approximately 22,400 syringes were distributed nationwide in the United States.
The recall was initiated based on a product complaint reporting glass particles in a syringe. Glass particles in an injectable product pose a risk of injection site injury or other harm if the product is administered to a patient.
This prescription medication is intended for subcutaneous or intravenous injection. The affected lot was distributed nationwide and may have reached healthcare facilities, hospitals, pharmacies, and other healthcare settings.
If you have this product, do not use it. Healthcare providers and patients who received this product should contact their pharmacy or healthcare provider. Return any affected product to your pharmacy or the manufacturer.
The recalled product
- Product
- OCTREOTIDE ACETATE (OCTREOTIDE ACETATE)
- Brand
- OCTREOTIDE ACETATE
- Manufacturer
- Viatris Inc
- Category
- Drug — Injectable
- Affected units
- 22,400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: AJ21002
- Exp. 03/2024
Distribution
Distributed nationwide across the United States.
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