FDAClass IIIOctober 23, 2019

Methylphenidate Hydrochloride Oral Solution 5mg per recall

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

Why was Methylphenidate Hydrochloride Oral Solution 5mg per recalled?

Presence of Foreign Substance; Fiber particles.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batch # 15315A, Exp. 02/2021

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…
Recalling firm
KVK-Tech, Inc.
Quantity
384 bottles
Distribution
Nationwide in the U.S.
Recall date
October 23, 2019
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls