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 7006…
SOMERSET THERAPEUTICS LLC · Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
- Status
- Ongoing
- City
- Somerset
- State
- NJ
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 94452
- Recalling firm
- SOMERSET THERAPEUTICS LLC
- Address 1
- 300 Franklin Square Dr
- Postal code
- 08873-4187
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States
- Recall number
- D-0506-2024
- 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).
- Recall initiation date
- 20240424
- Center classification date
- 20240521
- Report date
- 20240529
- Code info
- Lot #: a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025
- 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.