Drug product
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01
D-849-2013
Product summary
- Event
- Event 65515
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,579 bottles
- Official record key
drug-enforcement:D-849-2013
Official wording
Reason: Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
Code information: 34010287A, 34010288A, 34010289A, exp 4/2014; 34011513A, 34011514A, and 34011515A, exp 06/14.
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification