Trigen Laboratories: Drug Recall
Recall #D-0579-2024 · 06/17/2024
Class II: Risk
Recall Details
- Recall Number
- D-0579-2024
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Trigen Laboratories
- Status
- Terminated
- Date Initiated
- 06/17/2024
- Location
- Alpharetta, GA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- 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.
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
Distribution Pattern
Nationwide in the USA
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.