Why it was recalled
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
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.
Lot numbers, UPCs & expiration codes
Lot #: a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0506-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 24, 2024
- FDA report date
- May 29, 2024
- Quantity
- 5,578 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SOMERSET THERAPEUTICS LLC
Original FDA data
Every field from FDA enforcement report D-0506-2024, exactly as published.
Show all FDA fields
- City
- Somerset
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94452
- Address
- 300 Franklin Square Dr
- Code information
- Lot #: a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025
- Postal code
- 08873-4187
- Report date
- May 29, 2024
- Product type
- Drugs
- Recall number
- D-0506-2024
- Classification
- Class II
- Recalling firm
- SOMERSET THERAPEUTICS LLC
- Product quantity
- 5,578 units
- Reason for recall
- Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Apr 24, 2024
- Initial firm notification
- Letter
- Center classification date
- May 21, 2024