Drug Enforcement D-0579-2024

Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.

Status

Terminated

Classification

Class II

Report Date

July 10, 2024

Termination Date

September 23, 2025

Product Information

Product description
Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10
Product quantity
10,448 100-count bottles
Reason for recall
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Trigen Laboratories
Address
1880 Mcfarland Pkwy, ste 110

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0579-2024
Event ID
94818
Recall initiation date
June 17, 2024
Center classification date
July 2, 2024
Code info
Lot 230159M, Exp Date 2/28/2026
More code info
—