Drug product
Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12 bottles per case (NDC No. 66689-695-30), b). 1 liter (1000 mL), 4 bottles per case, (NDC No. 66689-695-79), Rx only, Manufactured by VistaPharm, Largo, FL 33771.
D-0465-2017
Product summary
- Firm
- VistaPharm, Inc.
- Event
- Event 75650
- Status
- Terminated
- Classification
- Class II
- Quantity
- 127,193 bottles
- Official record key
drug-enforcement:D-0465-2017
Official wording
Reason: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Code information: a). Lot No. 416600 (Exp. 09/17) b). Lot No.449100 , 447500 (Exp. 04/18), 421800 (Exp. 10/17), 418600 (Exp. 09/17), 408700 (Exp. 06/17), 411900 (Exp. 07/17), 413800 (Exp. 08/17), 416500 (Exp. 09/17), 408500 (Exp. 06/17), 389800 (Exp. 01/17), 429900 (Exp. 12/17), 406300, 406100 (Exp. 05/17), 429700 (Exp. 12/17), 427300, 427100, 425900 (11/17)
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Microbial contamination
contaminated with Burkholderia cepacia