Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10
Reported: July 10, 2024 Initiated: June 17, 2024 #D-0579-2024
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.
Details
- Recalling Firm
- Trigen Laboratories
- Units Affected
- 10,448 100-count bottles
- Distribution
- Nationwide in the USA
- Location
- Alpharetta, GA
Frequently Asked Questions
What product was recalled? ▼
Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10. Recalled by Trigen Laboratories. Units affected: 10,448 100-count bottles.
Why was this product recalled? ▼
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 10, 2024. Severity: Moderate. Recall number: D-0579-2024.
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