Drug Enforcement D-104-2013

Subpotent; 15 month stability

Status

Terminated

Classification

Class II

Report Date

January 2, 2013

Termination Date

January 3, 2014

Product Information

Product description
Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico Inc., for Alara Pharmaceutical Corp, San Juan, PR
Product quantity
7,432 bottles
Reason for recall
Subpotent; 15 month stability
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Alara Pharmaceutical Co
Address
270 Ave Munoz Rivera #301, N/A

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

Codes & Dates

Recall number
D-104-2013
Event ID
63608
Recall initiation date
October 29, 2012
Center classification date
December 21, 2012
Code info
11T7011A, Exp. Date: 12/2012
More code info
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