FDA Recall D-0325-2024

IntegraDose Compounding Services LLC · Minneapolis, MN

Class II Ongoing 843 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: 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

Quantity: 1,299 syringes

Reason for recall

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

Recall record

Recall number: D-0325-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: MN
Recall initiated: 2024-01-22
Classified by FDA Center: 2024-02-15
FDA published: 2024-02-21
Recalling firm: IntegraDose Compounding Services LLC
Firm location: Minneapolis, MN

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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