FDA Recalls Vasostrict Injection for Exceeding Potency Specifications
Par Sterile Products recalled Vasostrict (vasopressin) injection because stability testing showed the drug exceeded its upper potency specification limit. The recall involves 1,721 cartons distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II recall addresses a pharmaceutical quality defect in a potent vasoactive medication. Per the rubric, a 'risk-of-harm product where injury has not yet been reported' scores as High (3), which applies here as no illnesses or injuries are documented in the source text.
Plain-English summary
Vasostrict (vasopressin) injection, 20 units per 100 mL, is being recalled by Par Sterile Products LLC. The recall involves 1,721 cartons distributed nationwide with Lot Number 66702, expiring February 2025.
The recall was initiated because stability testing at 3 months and 6 months showed that the drug's potency exceeded the upper specification limit. This represents a manufacturing or quality control deviation.
Healthcare providers and institutions that dispensed this product should verify their inventory and quarantine any matching Lot 66702. Patients who received this medication should contact their healthcare provider.
The recalled product
- Product
- VASOSTRICT (VASOPRESSIN)
- Brand
- VASOSTRICT
- Manufacturer
- Par Sterile Products LLC
- Category
- Drug — Prescription Injection
- Affected units
- 1,721
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 # 66702
- Exp. 02/2025
Distribution
Distributed nationwide across the United States.
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