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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- SOMERSET THERAPEUTICS LLC
- Reason for Recall:
- Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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.
Product Codes/Lot Numbers:
Lot #: a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0506-2024
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