Class II
Terminated
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
This recall has been terminated (originally issued January 1, 2014).
- Company
- Amedra Pharmaceuticals Llc
- Recall Initiated
- October 7, 2013
- Posted
- January 1, 2014
- Recall Number
- D-385-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 10,992 bottles
- Firm Location
- Horsham, PA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.
Distribution
Nationwide
Lot / Code Info
Lot# 243459; Exp. 01/14
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