Drug product
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01
D-847-2013
Product summary
- Event
- Event 65515
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16,293 bottles
- Official record key
drug-enforcement:D-847-2013
Official wording
Reason: Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
Code information: 34010282A, 34010283A, 34010284A, 34010285A, 34010286A and 34010565A, exp 04/14; 34013199A, 34013200A, 34013201A, 34013202A and 34013203A, exp 10/14.
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification