FDA Drug recall D-0467-2017
Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33…
- FDA Drug
- Class II
- terminated
- Published 2017-02-08
On 2017-02-08 the FDA classified a Class II recall of Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33… by Vistapharm, citing CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0467-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-18 |
| Published | 2017-02-08 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Vistapharm |
| Distribution | US |
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.
Reason
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Identifiers
| code_info | Lot No. 388700 (Exp. 01/17) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0467-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.