Drug 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.
D-0466-2017
Product summary
- Firm
- VistaPharm, Inc.
- Event
- Event 75650
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,368 bottles
- Official record key
drug-enforcement:D-0466-2017
Official wording
Reason: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Code information: Lot No. 423000 (Exp. 10/17), 415100 (Exp. 08/17)
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Microbial contamination
contaminated with Burkholderia cepacia