FDARecalled Apr 16, 2025 · #D-0357-2025
Haloperidol 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 ...
Hazard
Class II — temporary health risk
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Lack of Assurance of Sterility: Media fill with bacterial contamination Classification: Class II Distribution: U.S. Nationwide
Product details
- Product
- Haloperidol 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)
- Type
- Drugs
- Manufacturer
- Somerset Therapeutics Private Limited
- Model numbers
- 68001-581-41, 68001-581-48
- UPCs
- —