D-0579-2024 Class II Terminated
FDA drug recall D-0579-2024 was initiated by Trigen Laboratories on June 17, 2024 and is designated Class II. Reason for recall: Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications. The recall status is terminated (terminated September 23, 2025). Affected quantity: 10,448 100-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 10, 2024
- Initiation Date
- June 17, 2024
- Termination Date
- September 23, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,448 100-count bottles
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
Reason for Recall
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Distribution Pattern
Nationwide in the USA
Code Information
Lot 230159M, Exp Date 2/28/2026