Recalls / Class II
Class IID-0232-2024
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
- Brand name
- Vasostrict
- Generic name
- Vasopressin
- Active ingredient
- Vasopressin, Unspecified
- Route
- Intravenous
- NDCs
- 42023-164, 42023-190, 42023-219, 42023-220, 42023-237, 42023-268
- FDA application
- NDA204485
- Affected lot / code info
- Lot # 66702; Exp. 02/2025
Why it was recalled
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Recalling firm
- Firm
- Par Sterile Products LLC
- Manufacturer
- Par Health USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 870 Parkdale Rd, N/A, Rochester, Michigan 48307-1740
Distribution
- Quantity
- 1721 cartons
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2024-01-11
- FDA classified
- 2024-01-16
- Posted by FDA
- 2024-01-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0232-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.