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D-0325-2024Class II

IntegraDose Compounding Services LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
IntegraDose Compounding Services LLC
Product type
Drug
Status
Ongoing
Report date
2024-02-21
Distribution
MN
Firm state
MN
Product quantity
1,299 syringes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Data Integrity
Reason for recall

Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.

Product description

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.

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →