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)
Reported: April 16, 2025 Initiated: March 21, 2025 #D-0355-2025
Product Description
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)
Reason for Recall
Lack of Assurance of Sterility: Media fill with bacterial contamination
Details
- Recalling Firm
- Somerset Therapeutics Private Limited
- Units Affected
- 997 vials
- Distribution
- U.S. Nationwide
- Location
- Bengaluru, N/A
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Somerset Therapeutics Private Limited. Units affected: 997 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Media fill with bacterial contamination
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 16, 2025. Severity: Moderate. Recall number: D-0355-2025.
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