Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000 mL), 4 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-695-79.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot No. 423000 (Exp. 10/17), 415100 (Exp. 08/17)
- 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:
- VistaPharm, Inc.
- Reason for Recall:
- CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000 mL), 4 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-695-79.
Product Codes/Lot Numbers:
Lot No. 423000 (Exp. 10/17), 415100 (Exp. 08/17)
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0466-2017
Related Recalls
Failed Excipient Specifications: high content of ethylene glycol (EG)
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.