Recalls / Class II
Class IID-0573-2022
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
- Brand name
- Methylphenidate Hydrochloride
- Generic name
- Methylphenidate Hydrochloride
- Active ingredient
- Methylphenidate Hydrochloride
- Route
- Oral
- NDCs
- 64980-221, 64980-222, 64980-223
- FDA application
- ANDA205756
- Affected lot / code info
- lot# 25910009, Exp 01/2023
Why it was recalled
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.
Recalling firm
- Firm
- RISING PHARMACEUTICALS
- Manufacturer
- Rising Pharma Holdings, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Tower Center Blvd, East Brunswick, New Jersey 08816-1100
Distribution
- Quantity
- 2220 100-count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-02-07
- FDA classified
- 2022-02-22
- Posted by FDA
- 2022-03-02
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0573-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.