Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceutic
Summary
The FDA issued a Class II for Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Onl by RISING PHARMACEUTICALS. Reason: Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a.
Details
Source
Drug Recall
External ID
D-0573-2022
Action Date
2022-03-02
Status
Ongoing
Category
drug
Product Description
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 Info: lot# 25910009, Exp 01/2023
Quantity Affected: 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.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-07
Company
East Brunswick, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 98 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
RISING PHARMACEUTICALS has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (RISING PHARMACEUTICALS) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does RISING PHARMACEUTICALS have FDA actions?
RISING PHARMACEUTICALS has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0573-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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