Haloperidol Decanoate Injection 100mg/mL recall: Sterility Concern
Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured…
Why was Haloperidol Decanoate Injection 100mg/mL recalled?
Lack of Assurance of Sterility: Media fill with bacterial contamination
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
NDC 68001-581-41; A240482A, exp. date 08/2026; NDC 68001-581-48; A240482B, exp. date 08/2026
- Product
- Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured…
- Recalling firm
- Somerset Therapeutics Private Limited
- Quantity
- 23,960 vials
- Distribution
- U.S. Nationwide
- Recall date
- April 16, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)