D-1430-2015 Class III Terminated
FDA drug recall D-1430-2015 was initiated by Novartis Pharmaceuticals Corp. on Jul 28, 2015 and is designated Class III. Reason for recall: 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. The recall status is terminated (terminated May 10, 2017). Affected quantity: 10,767 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Sep 23, 2015
- Initiation Date
- Jul 28, 2015
- Termination Date
- May 10, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,767 bottles
Product description
Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540
Reason for recall
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.
Distribution pattern
NJ - site for distributor
Code information
Lot #: F0002, Exp 12/2016
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1430-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026