Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-D
Summary
The FDA issued a Class II for Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials ( by SOMERSET THERAPEUTICS LLC. Reason: Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI)..
Details
Source
Drug Recall
External ID
D-0506-2024
Action Date
2024-05-29
Status
Ongoing
Category
drug
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/Code Info: Lot #: a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025
Quantity Affected: 5,578 units
Reason for Recall
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-24
Company
Somerset, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 25 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
SOMERSET THERAPEUTICS LLC has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SOMERSET THERAPEUTICS LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SOMERSET THERAPEUTICS LLC have FDA actions?
SOMERSET THERAPEUTICS LLC has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0506-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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