Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India.
Reported: May 29, 2024 Initiated: April 24, 2024 #D-0506-2024
Product Description
Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India.
Reason for Recall
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Details
- Recalling Firm
- SOMERSET THERAPEUTICS LLC
- Units Affected
- 5,578 units
- Distribution
- Nationwide within the United States
- Location
- Somerset, NJ
Frequently Asked Questions
What product was recalled? ▼
Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India.. Recalled by SOMERSET THERAPEUTICS LLC. Units affected: 5,578 units.
Why was this product recalled? ▼
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 29, 2024. Severity: Moderate. Recall number: D-0506-2024.
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