Drug recall D-0356-2025
Product
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41
Reason for recall
Lack of Assurance of Sterility: Media fill with bacterial contamination
Lots and codes
A240467B, exp. date 07/2026
Recall details
- Recalling firm
- Somerset Therapeutics Private Limited, Bengaluru, N/A
- Quantity
- 4956 vials
- Distribution
- U.S. Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 21, 2025
Related products
- Haloperidol Decanoate – drug information
- NDC 68001-581 Haloperidol Decanoate · Haloperidol Decanoate 100 mg/mL · BluePoint Laboratories
- NDC 68001-582 Haloperidol Decanoate · Haloperidol Decanoate 500 mg/5mL · BluePoint Laboratories
- NDC 68001-580 Haloperidol Decanoate · Haloperidol Decanoate 50 mg/mL · BluePoint Laboratories
- NDC 68001-578 Haloperidol Decanoate · Haloperidol Decanoate 50 mg/mL · BluePoint Laboratories
- NDC 68001-579 Haloperidol Decanoate · Haloperidol Decanoate 100 mg/mL · BluePoint Laboratories