FDAHealthMarch 21, 2025
Somerset Therapeutics Private Limited — Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (indi
⚠️ Lack of Assurance of Sterility: Media fill with bacterial contamination
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 21, 2025
U.S. Nationwide
What's affected?
- Product
- Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 mL carton)
- UPC
- 0370069382011
- Lot code
- NDC 70069-381-01; A240467A, exp. date 07/2026; NDC 70069-381-10; A240467C, exp. date 07/2026
Additional details
NDC 70069-381-01; A240467A, exp. date 07/2026; NDC 70069-381-10; A240467C, exp. date 07/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 997 vials.
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