Drug product
Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-711-16.
D-0467-2017
Product summary
- Firm
- VistaPharm, Inc.
- Event
- Event 75650
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,354 bottles
- Official record key
drug-enforcement:D-0467-2017
Official wording
Reason: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Code information: Lot No. 388700 (Exp. 01/17)
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Microbial contamination
contaminated with Burkholderia cepacia