FDA-Drug2022-03-02Class II

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

RISING PHARMACEUTICALS
Hazard

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.

Sold states
Nationwide in the USA
Affected count
2220 100-count bottles
Manufactured in
2 Tower Center Blvd, East Brunswick, NJ, United States
Products
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

Official notice

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

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