Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL amber bottle, Rx Only, Manufactured by Silarx Pharmaceuticals Inc. Carmel, NY 10512, Packaged by Safecor Health, Woburn, MA 01801, NDC 54838-0501-40.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #846881; Exp 01/16
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Safecor Health, LLC
- Reason for Recall:
- Defective Container: Confirmed customer complaints of leaking bottles.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL amber bottle, Rx Only, Manufactured by Silarx Pharmaceuticals Inc. Carmel, NY 10512, Packaged by Safecor Health, Woburn, MA 01801, NDC 54838-0501-40.
Product Codes/Lot Numbers:
Lot #846881; Exp 01/16
Distribution:
Distributed in: NJ
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0661-2016
Related Recalls
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.