Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, So
Summary
The FDA issued a Class II for Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufact by Somerset Therapeutics Private Limited. Reason: Lack of Assurance of Sterility: Media fill with bacterial contamination.
Details
Source
Drug Recall
External ID
D-0355-2025
Action Date
2025-04-16
Status
Ongoing
Category
drug
Product Description
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 mL carton)
Lot/Code Info: NDC 70069-381-01; A240467A, exp. date 07/2026; NDC 70069-381-10; A240467C, exp. date 07/2026
Quantity Affected: 997 vials
Reason for Recall
Lack of Assurance of Sterility: Media fill with bacterial contamination
Distribution
U.S. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-21
Company
Bengaluru, N/A
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 86 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Somerset Therapeutics Private Limited has 5 FDA actions in our database, including 5 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 Private Limited) 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 Private Limited have FDA actions?
Somerset Therapeutics Private Limited has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0355-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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