Drug Enforcement D-0355-2025

Lack of Assurance of Sterility: Media fill with bacterial contamination

Status

Ongoing

Classification

Class II

Report Date

April 16, 2025

Termination Date

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Product Information

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)
Product quantity
997 vials
Reason for recall
Lack of Assurance of Sterility: Media fill with bacterial contamination
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
U.S. Nationwide

Location & Firm

Recalling firm
Somerset Therapeutics Private Limited
Address
54/1 Budihal Village, N/A

India
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0355-2025
Event ID
96569
Recall initiation date
March 21, 2025
Center classification date
April 8, 2025
Code info
NDC 70069-381-01; A240467A, exp. date 07/2026; NDC 70069-381-10; A240467C, exp. date 07/2026
More code info
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