D-385-2014 Class II Terminated
FDA drug recall D-385-2014 was initiated by Amedra Pharmaceuticals LLC on October 7, 2013 and is designated Class II. Reason for recall: Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level. The recall status is terminated (terminated October 7, 2014). Affected quantity: 10,992 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 1, 2014
- Initiation Date
- October 7, 2013
- Termination Date
- October 7, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,992 bottles
Product Description
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
Reason for Recall
Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.
Distribution Pattern
Nationwide
Code Information
Lot# 243459; Exp. 01/14