FDA recall D-0573-2022

RISING PHARMACEUTICALS · Class II · drug

Product

Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., Saddle Brook, NJ 07863, NDC 64980-221-01

Reason for recall

Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.

Distribution

Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2022-02-07
Report date
2022-03-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
East Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0573-2022