Dexmethylphenidate HCl Extended-Release recall: Failed Dissolution
Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for…
Why was Dexmethylphenidate HCl Extended-Release recalled?
Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: F0002, Exp 12/2016
- Product
- Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for…
- Recalling firm
- Novartis Pharmaceuticals Corp.
- Quantity
- 10,767 bottles
- Distribution
- NJ - site for distributor
- Recall date
- September 23, 2015
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)