Reported May 29, 2024 · Ongoing
Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL…
Somerset Therapeutics LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SOMERSET THERAPEUTICS LLC · 300 Franklin Square Dr · Somerset, NJ · 08873-4187
Is this the product you have?
- 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 forSomerset Therapeutics, LLC, Hollywood, FL 33024, Made in India
- Lot codes and dates
Lot #: a) A230412AExp. Date 07/2025b)A230412BExp. Date 07/2025
- Amount recalled
- 5,578 units
Where it was sold
- Nationwide
Why it was recalled
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
This product could cause temporary or reversible health problems — stop using it.
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