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.
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
Lot numbers, UPCs & expiration codes
Lot #: F0002, Exp 12/2016
Where it was sold
NJ - site for distributor
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1430-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 28, 2015
- FDA report date
- Sep 23, 2015
- Quantity
- 10,767 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novartis Pharmaceuticals Corp.
Original FDA data
Every field from FDA enforcement report D-1430-2015, exactly as published.
Show all FDA fields
- City
- Suffern
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 71830
- Address
- 25 Old Mill Rd
- Code information
- Lot #: F0002, Exp 12/2016
- Postal code
- 10901-4106
- Report date
- Sep 23, 2015
- Product type
- Drugs
- Recall number
- D-1430-2015
- Classification
- Class III
- Recalling firm
- Novartis Pharmaceuticals Corp.
- Product quantity
- 10,767 bottles
- Termination date
- May 10, 2017
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- NJ - site for distributor
- Recall initiation date
- Jul 28, 2015
- Initial firm notification
- Letter
- Center classification date
- Sep 14, 2015