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.

FDA recall notice · announced October 23, 2019 · Kvk-tech

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the U.S.
Lot/code information: Batch # 15315A, Exp. 02/2021
Quantity: 384 bottles
Status: Terminated
Products in this recall event:
- 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. (D-0142-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.