Drug product
Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle, Rx only, Manufactured by Catalent Pharma Solutions Winchester, KY 40391 for Amedra Pharmaceuticals, LLC Middlesex, NJ 08846, NDC 52054-514-09
D-385-2014
Product summary
- Event
- Event 66593
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,992 bottles
- Official record key
drug-enforcement:D-385-2014
Official wording
Reason: Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.
Code information: Lot# 243459; Exp. 01/14
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out of Specification