The Recall Desk
HighFDA (Drugs)·D-0232-2024·Announced 2024-01-24

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.

What this means for you

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
Hazard
  • superpotency
  • quality-defect

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.