Drug recall D-0368-2025
Product
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.
Reason for recall
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Lots and codes
A240482A, EXP 08/31/2026
Recall details
- Recalling firm
- Amerisource Health Services LLC, Columbus, OH
- Quantity
- 14,189 vials
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 2, 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