Recalls / Class III
Class IIID-1430-2015
Product
Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540
- Affected lot / code info
- Lot #: F0002, Exp 12/2016
Why it was 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.
Recalling firm
- Firm
- Novartis Pharmaceuticals Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 25 Old Mill Rd, Suffern, New York 10901-4106
Distribution
- Quantity
- 10,767 bottles
- Distribution pattern
- NJ - site for distributor
Timeline
- Recall initiated
- 2015-07-28
- FDA classified
- 2015-09-14
- Posted by FDA
- 2015-09-23
- Terminated
- 2017-05-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1430-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.