Drug product
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01
D-848-2013
Product summary
- Event
- Event 65515
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,478 bottles
- Official record key
drug-enforcement:D-848-2013
Official wording
Reason: Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
Code information: 34010290A, 34010291A, 34010292A, exp 04/14, 34011855A, 34011856A, 34011857A, 34011858A, 34013216A, 34013217A, 34013218A, exp 06/14.
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification