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Recall Enforment Report D-0354-2025

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Somerset Therapeutics Private Limited, originally initiated on 03-21-2025 for the product Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-101-25 (immediate carton) and 70069-101-05 (5x10 mL carton) The product was recalled due to lack of assurance of sterility: media fill with bacterial contamination. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0354-202503-21-202504-16-2025Class II506,080 vialsMethocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-101-25 (immediate carton) and 70069-101-05 (5x10 mL carton)Lack of Assurance of Sterility: Media fill with bacterial contaminationOngoing
D-0356-202503-21-202504-16-2025Class II4956 vialsHaloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41Lack of Assurance of Sterility: Media fill with bacterial contaminationOngoing
D-0358-202503-21-202504-16-2025Class II240 vialsHaloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-383-10Lack of Assurance of Sterility: Media fill with bacterial contaminationOngoing
D-0355-202503-21-202504-16-2025Class II997 vialsHaloperidol 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)Lack of Assurance of Sterility: Media fill with bacterial contaminationOngoing
D-0357-202503-21-202504-16-2025Class II23,960 vialsHaloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (individual carton) and NDC 68001-581-48 (5x1 mL cartons)Lack of Assurance of Sterility: Media fill with bacterial contaminationOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
68001-578Haloperidol Decanoate Haloperidol DecanoateInjectionIntramuscularBluepoint LaboratoriesHuman Prescription Drug
68001-579Haloperidol Decanoate Haloperidol DecanoateInjectionIntramuscularBluepoint LaboratoriesHuman Prescription Drug
68001-580Haloperidol Decanoate Haloperidol DecanoateInjectionIntramuscularBluepoint LaboratoriesHuman Prescription Drug
68001-581Haloperidol Decanoate Haloperidol DecanoateInjectionIntramuscularBluepoint LaboratoriesHuman Prescription Drug
68001-582Haloperidol Decanoate Haloperidol DecanoateInjectionIntramuscularBluepoint LaboratoriesHuman Prescription Drug
70069-030Haloperidol Decanoate Haloperidol DecanoateInjectionIntramuscularSomerset Therapeutics, LlcHuman Prescription Drug
70069-031Haloperidol Decanoate Haloperidol DecanoateInjectionIntramuscularSomerset Therapeutics, LlcHuman Prescription Drug
70069-101Methocarbamol MethocarbamolInjectionIntramuscular; IntravenousSomerset Therapeutics, LlcHuman Prescription Drug
70069-381Haloperidol Decanoate Haloperidol DecanoateInjectionIntramuscularSomerset Therapeutics, LlcHuman Prescription Drug
70069-382Haloperidol Decanoate Haloperidol DecanoateInjectionIntramuscularSomerset Therapeutics, LlcHuman Prescription Drug
70069-383Haloperidol Decanoate Haloperidol DecanoateInjectionIntramuscularSomerset Therapeutics, LlcHuman Prescription Drug
70069-384Haloperidol Decanoate Haloperidol DecanoateInjectionIntramuscularSomerset Therapeutics, LlcHuman Prescription Drug