Drug recall D-0466-2017
Product
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.
Reason for recall
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Lots and codes
Lot No. 423000 (Exp. 10/17), 415100 (Exp. 08/17)
Recall details
- Recalling firm
- VistaPharm, Inc., Largo, FL
- Quantity
- 14,368 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 18, 2017
- Terminated
- August 26, 2021
Related products
- Methadone Hydrochloride – drug information
- NDC 66689-694 Methadone Hydrochloride · Methadone Hydrochloride 10 mg/mL · VistaPharm, LLC
- NDC 66689-695 Methadone Hydrochloride · Methadone Hydrochloride 10 mg/mL · VistaPharm, LLC