Drug Enforcement D-385-2014

Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.

Status

Terminated

Classification

Class II

Report Date

January 1, 2014

Termination Date

October 7, 2014

Product Information

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
Product quantity
10,992 bottles
Reason for recall
Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Amedra Pharmaceuticals LLC
Address
2 Walnut Grove Dr, Suite 190

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-385-2014
Event ID
66593
Recall initiation date
October 7, 2013
Center classification date
December 23, 2013
Code info
Lot# 243459; Exp. 01/14
More code info
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