Recalls / Class II
Class IID-0506-2024
Product
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.
- Brand name
- Haloperidol Decanoate
- Generic name
- Haloperidol Decanoate
- Active ingredient
- Haloperidol Decanoate
- Route
- Intramuscular
- NDCs
- 70069-030, 70069-031, 70069-381, 70069-382, 70069-383, 70069-384
- FDA application
- ANDA209101
- Affected lot / code info
- Lot #: a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025
Why it was recalled
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Recalling firm
- Firm
- SOMERSET THERAPEUTICS LLC
- Manufacturer
- Somerset Therapeutics, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 300 Franklin Square Dr, Somerset, New Jersey 08873-4187
Distribution
- Quantity
- 5,578 units
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2024-04-24
- FDA classified
- 2024-05-21
- Posted by FDA
- 2024-05-29
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0506-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.