Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico ...
FDA Recall #D-104-2013 — Class II — October 29, 2012
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
Reason for Recall
Subpotent; 15 month stability
Recalling Firm
Alara Pharmaceutical Co — San Juan, PR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
7,432 bottles
Distribution
Nationwide
Code Information
11T7011A, Exp. Date: 12/2012
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated