FDA Recall D-0232-2024

Par Sterile Products LLC · Rochester, MI

Class II Ongoing 854 days on record

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

Product

Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials per carton, Ready to Use, For Intravenous Infusion, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-237-10

Lot / code: Lot # 66702; Exp. 02/2025

Quantity: 1721 cartons

Reason for recall

Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.

Recall record

Recall number: D-0232-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide USA
Recall initiated: 2024-01-11
Classified by FDA Center: 2024-01-16
FDA published: 2024-01-24
Recalling firm: Par Sterile Products LLC
Firm location: Rochester, MI

Drug identification

Brand name(s): VASOSTRICT
Generic name(s): VASOPRESSIN
Manufacturer(s): Par Health USA, LLC
NDC(s): 42023-164, 42023-190, 42023-219, 42023-220, 42023-237, 42023-268
Route(s): INTRAVENOUS

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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