January 2024 FDA Recall Drug by Integradose Compounding Services Llc
D-0325-2024 - Sub-potent drug

This Class II drug recall was voluntarily initiated by Integradose Compounding Services Llc on January 22, 2024 for the product Drug. The FDA reported the reason for recall as sub-potent drug. The product was distributed in MN and the recall is currently ongoing.

Recall Number: D-0325-2024

Reason for Recall
Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
Initiated
01-22-2024
Reported
02-21-2024
Quantity
1,299 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93940
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
IntegraDose Compounding Services LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MN
Product Description About Product Description
Full technical description of the product.
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. Office Use Only, NDC 71139-0190-1.

Batch or Lot Expiration Information

Lot# s: 20230929VAS-2, Exp. 02/29/2024; 20231004VAS-2, Exp. 04/01/2024; Lot 20231010VAS-2,Exp. 04/07/2024; Lot 20231013VAS-2, Exp. 04/10/2024