FDA recall D-0297-2021

Teva Pharmaceuticals USA · Class II · drug

Product

Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, Rx only, Distributed by Teva Pharmaceuticals, USA, Inc., Parsippany, NJ Vial NDC 0703-4502-01 (vial) NDC# 0703-4502-04 (tray)

Reason for recall

Chemical contamination; Unknown brown residue adhering to the inside of one vial.

Distribution

Nationwide, including Puerto Rico

Key facts

Status
Terminated
Initiation date
2021-02-15
Report date
2021-03-10
Termination date
2021-08-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0297-2021