FDA Recall D-0573-2022

RISING PHARMACEUTICALS · East Brunswick, NJ

Class II Ongoing 1557 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: lot# 25910009, Exp 01/2023

Quantity: 2220 100-count bottles

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.

Recall record

Recall number: D-0573-2022
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2022-02-07
Classified by FDA Center: 2022-02-22
FDA published: 2022-03-02
Recalling firm: RISING PHARMACEUTICALS
Firm location: East Brunswick, NJ

Drug identification

Brand name(s): METHYLPHENIDATE HYDROCHLORIDE
Generic name(s): METHYLPHENIDATE HYDROCHLORIDE
Manufacturer(s): Rising Pharma Holdings, Inc.
NDC(s): 64980-221, 64980-222, 64980-223
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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