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)
Reported: April 16, 2025 Initiated: March 21, 2025 #D-0357-2025
Product Description
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)
Reason for Recall
Lack of Assurance of Sterility: Media fill with bacterial contamination
Details
- Recalling Firm
- Somerset Therapeutics Private Limited
- Units Affected
- 23,960 vials
- Distribution
- U.S. Nationwide
- Location
- Bengaluru, N/A
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Somerset Therapeutics Private Limited. Units affected: 23,960 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Media fill with bacterial contamination
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 16, 2025. Severity: Moderate. Recall number: D-0357-2025.
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