FDA recall D-0010-2015

VistaPharm, Inc. · Class II · drug

Product

METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), 10 mL cups, Rx only. Manufactured by VistaPharm Inc., Largo, FL 33771. NDC 66689-031-01.

Reason for recall

Defective Container: Product leaks when inverted.

Distribution

U.S. Nationwide, including Puerto Rico

Key facts

Status
Terminated
Initiation date
2014-08-13
Report date
2014-10-15
Termination date
2015-02-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Largo, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0010-2015