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Somerset Therapeutics Private Limited FDA Recalls

5 recalls on file across drugs, 0 of them Class I and 5 still open. This firm is not matched to a listed company.

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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Class IIMar 21, 2025Lack of Assurance of Sterility: Media fill with bacterial co
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, SoClass IIMar 21, 2025Lack of Assurance of Sterility: Media fill with bacterial co
Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset TherClass IIMar 21, 2025Lack of Assurance of Sterility: Media fill with bacterial co
Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC,Class IIMar 21, 2025Lack of Assurance of Sterility: Media fill with bacterial co
Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited,Class IIMar 21, 2025Lack of Assurance of Sterility: Media fill with bacterial co

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