Drug product
Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10
D-0579-2024
Product summary
- Event
- Event 94818
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,448 100-count bottles
- Official record key
drug-enforcement:D-0579-2024
Official wording
Reason: Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Code information: Lot 230159M, Exp Date 2/28/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed dissolution specifications