FDA recall D-0142-2020

Product

Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free, Rx Only, Mfd by: KVK Tech, Inc., Newtown, PA 18940, NDC 10702-0163-50.

Reason for recall

Presence of Foreign Substance; Fiber particles.

Distribution

Nationwide in the U.S.

Key facts

Status

Terminated

Initiation date

2019-10-04

Report date

2019-10-23

Termination date

2020-04-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Newtown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0142-2020