← FDA ENFORCEMENT
D-0368-2025Class II

Amerisource Health Services LLC

Recalling firm
Amerisource Health Services LLC
Product type
Drug
Status
Ongoing
Report date
2025-04-30
Distribution
Nationwide in the USA
Firm state
OH
Product quantity
14,189 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

Product description

Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for BluePoint Laboratories, NDC 68001-581-41.

Code / lot info

A240482A, EXP 08/31/2026

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.